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A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

Primary Purpose

Locally Advanced or Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Phesgo
Giredestrant
Docetaxel
Paclitaxel
LHRH Agonist
Optional Endocrine Therapy of Investigator's Choice
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
  • At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Left ventricular ejection fraction (LVEF) of at least (≥)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of Phesgo
  • For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo

Maintenance Phase Inclusion Criteria

  • Complete a minimum of four cycles of induction therapy
  • Achieve a minimum of stable disease (SD) (or Non-complete response [CR]/Non-progressive disease [PD] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
  • LVEF of ≥50% at the last assessment during the induction therapy phase

Exclusion Criteria:

  • Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
  • Prior treatment with a selective estrogen receptor degrader (SERD)
  • Previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting
  • Disease progression within 6 months of receiving trastuzumab, with or without pertuzumab, or ado-trastuzumab emtansine in the adjuvant setting
  • Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
  • History of persistent Grade ≥2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy
  • History of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2.
  • Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  • Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of Phesgo
  • Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of induction therapy
  • Treated with investigational therapy within 28 days prior to initiation of induction therapy
  • Treated with localized palliative radiotherapy within 14 days prior to initiation of induction therapy
  • Concurrent participation in any other therapeutic clinical trial
  • Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies
  • Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent)
  • Poorly controlled hypertension
  • Known clinically significant history of liver disease
  • Active cardiac disease or history of cardiac dysfunction
  • Major surgical procedure or significant traumatic injury within 14 days prior to enrollment or anticipation of need for major surgery during induction therapy
  • Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery
  • Concurrent, serious, uncontrolled infections, or known infection with HIV with the following exception: Individuals who are HIV positive are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥200 cells/uL, and have an undetectable viral load and no history of AIDS-defining opportunistic infections within 12 months prior to enrollment.
  • Serious COVID-19 infection within 14 days prior to enrollment; however, no screening testing for SARS-CoV-2 is required
  • Serious infection requiring oral or IV antibiotics within 7 days prior to screening
  • Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in the study
  • History of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
  • For pre- and perimenopausal women, and men: Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa); Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy that requires gonadal function suppression

Sites / Locations

  • Genesis Cancer CenterRecruiting
  • Los Angeles Hematology Oncology Medical GroupRecruiting
  • St Mary's Hospital and Medical CenterRecruiting
  • Cancer Specialists of North Florida
  • Florida Cancer Specialists - EAST - SCRI - PPDSRecruiting
  • Maryland Oncology Hematology - AnnapolisRecruiting
  • Swedish Cancer InstituteRecruiting
  • Hightower ClinicalRecruiting
  • West Cancer CenterRecruiting
  • Texas Oncology - AustinRecruiting
  • Texas Oncology-Baylor Sammons Cancer CenterRecruiting
  • Texas Oncology - El Paso
  • Virginia Oncology AssociatesRecruiting
  • Swedish Cancer Institute - Edmonds CampusRecruiting
  • Swedish Cancer Institute - IssaquahRecruiting
  • Fundación CENIT para la Investigación en NeurocienciasRecruiting
  • Centro Oncologico Korben; OncologyRecruiting
  • Centro Oncologico Riojano Integral (CORI)Recruiting
  • Fundacion ScherbovskyRecruiting
  • Instituto de Oncología de Rosario
  • Hospital Provincial del CentenarioRecruiting
  • CER San Juan Centro Polivalente de Asistencia e Investigacion ClinicaRecruiting
  • Cliniques Universitaires St-LucRecruiting
  • GHdC Site Notre DameRecruiting
  • UZ GentRecruiting
  • Jessa Zkh (Campus Virga Jesse)Recruiting
  • UZ Leuven GasthuisbergRecruiting
  • Clinique Ste-ElisabethRecruiting
  • Hospital Sao Rafael - HSRRecruiting
  • Pronutrir - suporte nutricional e quimioterapia ltda.
  • Hospital Araujo Jorge; Departamento de Ginecologia E MamaRecruiting
  • Hospital do Cancer de Pernambuco - HCPRecruiting
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Hospital Nossa Senhora da ConceicaoRecruiting
  • Fundação Pio XII Hospital de Câncer de BarretosRecruiting
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting
  • Affiliated Hospital of Hebei University; Department of medical oncology
  • Peking University People's HospitalRecruiting
  • the First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Hunan Cancer HospitalRecruiting
  • Sichuan Cancer HospitalRecruiting
  • West China Hospital - Sichuan UniversityRecruiting
  • No. 900 Hospital (Fuzhou General Hospital)Recruiting
  • Fujian Cancer HospitalRecruiting
  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer departmentRecruiting
  • Zhejiang Provincial People?s Hospital
  • Shandong Cancer HospitalRecruiting
  • The First Affiliated Hospital Of Jinzhou Medical University
  • Yunnan Cancer HospitalRecruiting
  • The Third Hospital of NanchangRecruiting
  • Jiangxi Cancer HospitalRecruiting
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)Recruiting
  • Jiangsu Cancer HospitalRecruiting
  • Guangxi Cancer Hospital of Guangxi Medical University
  • Liaoning Provincial Cancer Hospital
  • The First Affiliated Hospital of China Medical University
  • Tianjin Cancer HospitalRecruiting
  • The Tumor Hospital of Xinjiang Medical UniversityRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Xian Jiao Tong UniversityRecruiting
  • Clinica De La Costa
  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento AnguloRecruiting
  • Clinica Colsanitas S.A. sede Clinica Universitaria ColombiaRecruiting
  • Oncomedica S.A.Recruiting
  • Oncólogos de OccidenteRecruiting
  • Institut Sainte Catherine;Recherche CliniqueRecruiting
  • CH de la Côte Basque - Hôpital de BayonneRecruiting
  • CHU Besançon - Hôpital Jean MinjozRecruiting
  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie RadiotherapieRecruiting
  • CHU de GRENOBLERecruiting
  • CHD VendéeRecruiting
  • Hopital Prive Jean MermozRecruiting
  • INSTITUT CURIE_Site ParisRecruiting
  • Centre Catalan D' OncologieRecruiting
  • Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim; Gynäkologie/ onkolog. TagesklinikRecruiting
  • Sozialstiftung Bamberg, Klinikum am Bruderwald, GynäkologieRecruiting
  • Onkologische Schwerpunktpraxis KurfürstendammRecruiting
  • Gynäkologisches Zentrum BonnRecruiting
  • Onkozentrum Dres. GöhlerRecruiting
  • Kliniken Essen-MitteRecruiting
  • Universitätsklinikum Freiburg; FrauenklinikRecruiting
  • HOPA MVZ GmbHRecruiting
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum HeidelbergRecruiting
  • Ärztehaus am Bahnhofsplatz; Praxis Uleer/PourfardRecruiting
  • Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und GeburtshilfeRecruiting
  • Dres. Andreas Köhler und Roswitha FuchsRecruiting
  • Studienzentrum Onkologie Ravensburg GbR; Onkologie RavensburgRecruiting
  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/OnkologieRecruiting
  • Budapesti Szent Margit Korhaz; Onkologia OsztalyRecruiting
  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephelyRecruiting
  • Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz; Onkologiai KözpontRecruiting
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz; Onkologiai OsztalyRecruiting
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai KozpontRecruiting
  • Komarom-Eszergom Varmegyei Szent Borbala Korhaz; Onkologiai OsztalyRecruiting
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
  • Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCSRecruiting
  • Ospedale Infermi AUSL della Romagna; U.O Operativa di OncologiaRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
  • Istituto Europeo Di OncologiaRecruiting
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed EmatologiaRecruiting
  • Humanitas Centro Catanese Di Oncologia; Oncologia Medica
  • Ospedale Civile; Unita Operativa Di Oncologia MedicaRecruiting
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica IIRecruiting
  • Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
  • International Cancer Institute (ICI)Recruiting
  • Aga Khan University HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • National Cancer Center
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical Center
  • Gangnam Severance HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St Mary's HospitalRecruiting
  • Investigacion OncofarmaceuticaRecruiting
  • Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
  • Health Pharma Professional ResearchRecruiting
  • Iem-FucamRecruiting
  • Filios Alta MedicinaRecruiting
  • Hospital Universitario; Dr. Jose E. GonzalezRecruiting
  • Hospital Zambrano Hellion TecSaludRecruiting
  • Cuidados oncologicosRecruiting
  • Oncologico PotosinoRecruiting
  • Centro Estatal de Cancerologia de Chihuahua; ONCOLOGYRecruiting
  • Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial DziennyRecruiting
  • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
  • Ars Medical Sp. z o. o.Recruiting
  • Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
  • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w RzeszowieRecruiting
  • IPO de Coimbra; Servico de Oncologia MedicaRecruiting
  • Hospital de S. Francisco Xavier; Unidade de Oncologia MedicaRecruiting
  • Hospital Beatriz Angelo; Departamento de OncologiaRecruiting
  • IPO do Porto; Servico de Oncologia MedicaRecruiting
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de OncologiaRecruiting
  • Hospital Universitario de Canarias;servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de OncologíaRecruiting
  • Hospital Universitario La Paz; Servicio de OncologiaRecruiting
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de OncologiaRecruiting
  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio OncologiaRecruiting
  • Changhua Christian Hospital; Dept of SurgeryRecruiting
  • China Medical University Hospital; SurgeryRecruiting
  • National Cheng Kung University Hospital; OncologyRecruiting
  • National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center
  • Taipei Veterans General Hospital Office of General SurgeryRecruiting
  • Rajavithi Hospital; Division of Medical OncologyRecruiting
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. OncRecruiting
  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical TrialRecruiting
  • Songklanagarind Hospital; Department of OncologyRecruiting
  • Adana Baskent University Hospital; Medical Oncology
  • Ankara Oncology Hospital; OncologyRecruiting
  • Gazi Uni Medical Faculty Hospital; Oncology DeptRecruiting
  • Ankara City Hospital; OncologyRecruiting
  • Uludag Uni Hospital; OncologyRecruiting
  • Dicle University Faculty of Medicine
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan YerleskesiRecruiting
  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology DepartmentRecruiting
  • Medipol University Medical Faculty; Oncology DepartmentRecruiting
  • Prof. Dr. Cemil Tascioglu City Hospital; Med OncRecruiting
  • Ege Uni Medical Faculty; Oncology DeptRecruiting
  • Katip Celebi University Ataturk Training and Research Hospital; Oncology
  • Kocaeli University Faculty of Medicine; Medical oncologyRecruiting
  • Erciyes Uni ; Medical Oncology
  • Antalya Memorial Hastanesi; OnkolojiRecruiting
  • Mersin City Education and Research HospitalRecruiting
  • Ondokuz Mayis Univ. Med. Fac.Recruiting
  • Ac?badem Maslak Hastanesi Büyükdere
  • Medical Park Seyhan Hospital; Oncology DepartmentRecruiting
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
  • Karadeniz Tecnical University Medical Faculty; Oncology Department
  • Ac?badem Altunizade Hastanesi; OncologyRecruiting
  • University Hospital North TeesRecruiting
  • Royal Cornwall Hospital; Dept of Clinical OncologyRecruiting
  • Charing Cross Hospital; Medical Oncology.Recruiting
  • Maidstone Hospital; Kent Oncology CentreRecruiting
  • Nottingham University Hospitals NHS Trust - City HospitalRecruiting
  • Royal Preston Hosp; Rosemere Cancer CtrRecruiting
  • Queen's Hospital; OncologyRecruiting
  • Singleton Hospital; Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Experimental

Arm Label

Induction Therapy: Phesgo plus Taxane-Based Chemotherapy

Arm A, Maintenance Therapy: Phesgo

Arm B, Maintenance Therapy: Giredestrant plus Phesgo

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1

Secondary Outcome Measures

Overall Survival
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart.
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response (CR) or partial response (PR).
Mean Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Mean Change from Baseline in the Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Mean Physical Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Mean Change from Baseline in the Physical Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Mean Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Mean Change from Baseline in the Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Number of Participants with at Least One Adverse Event, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0)
Number of Participants with Abnormalities in Clinical Laboratory Test Results

Full Information

First Posted
March 23, 2022
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05296798
Brief Title
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
Official Title
A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
September 30, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
812 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Arm Type
Other
Arm Title
Arm A, Maintenance Therapy: Phesgo
Arm Type
Active Comparator
Arm Title
Arm B, Maintenance Therapy: Giredestrant plus Phesgo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Phesgo
Other Intervention Name(s)
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, Pertuzumab, Trastuzumab, and rHuPH20, Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), RO7198574, RG6264
Intervention Description
Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase [rHuPH20]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W).
Intervention Type
Drug
Intervention Name(s)
Giredestrant
Other Intervention Name(s)
GDC-9545, RO7197597, RG6171
Intervention Description
A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Docetaxel will be administered at 75 milligrams per metre squared of body surface area (mg/m2) intravenously over 60 (±10) minutes on Day 1 of each cycle for 4 to 8 cycles (a cycle is 21 days); this dose may be escalated to 100 mg/m2 if the initial dose was well tolerated.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Paclitaxel will be administered at 80 milligrams per metre squared of body surface area (mg/m2) intravenously over a minimum of 1 hour on Days 1, 8, and 15 of each cycle for 4 to 8 cycles (a cycle is 21 days); this weekly regimen is considered as one complete cycle whenever 3 weekly doses are given.
Intervention Type
Drug
Intervention Name(s)
LHRH Agonist
Intervention Description
A luteinizing hormone-releasing hormone (LHRH) agonist will be administered every 28 days to pre- and peri-menopausal women and all male participants while receiving giredestrant in Arm B. An LHRH agonist may be administered to male participants and pre- and peri-menopausal female participants receiving tamoxifen in Arm A, and should be administered to those receiving an aromatase inhibitor in Arm A. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Intervention Type
Drug
Intervention Name(s)
Optional Endocrine Therapy of Investigator's Choice
Intervention Description
For participants in Arm A, optional endocrine therapy of investigator's choice is allowed based on the standard of care, and it can include an aromatase inhibitor or tamoxifen with or without an LHRH agonist, or gonadal ablation. The decision to include or exclude this option must be made prior to randomization.
Primary Outcome Measure Information:
Title
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
Time Frame
From randomization for maintenance therapy to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From randomization for maintenance therapy to death from any cause (up to 122 months)
Title
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
Description
The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart.
Time Frame
From randomization for maintenance therapy to disease progression or death (up to 50 months)
Title
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Time Frame
From first occurrence of documented objective response after randomization for maintenance therapy to disease progression or death from any cause, whichever occurs first (up to 50 months)
Title
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Description
The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response (CR) or partial response (PR).
Time Frame
From randomization for maintenance therapy to disease progression or death (up to 50 months)
Title
Mean Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame
Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years)
Title
Mean Change from Baseline in the Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame
Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years)
Title
Mean Physical Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame
Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years)
Title
Mean Change from Baseline in the Physical Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame
Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years)
Title
Mean Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame
Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years)
Title
Mean Change from Baseline in the Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame
Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years)
Title
Number of Participants with at Least One Adverse Event, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0)
Time Frame
From Baseline until 28 days after the final dose of study treatment (up to 10 years, 3 months)
Title
Number of Participants with Abnormalities in Clinical Laboratory Test Results
Time Frame
From Baseline until 28 days after the final dose of study treatment (up to 10 years, 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Left ventricular ejection fraction (LVEF) of at least (≥)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) Adequate hematologic and end-organ function For women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of Phesgo For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo Maintenance Phase Inclusion Criteria Complete a minimum of four cycles of induction therapy Achieve a minimum of stable disease (SD) (or Non-complete response [CR]/Non-progressive disease [PD] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase LVEF of ≥50% at the last assessment during the induction therapy phase Exclusion Criteria: Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed. Prior treatment with a selective estrogen receptor degrader (SERD) Previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting Disease progression within 6 months of receiving adjuvant anti-HER2 therapy (such as trastuzumab, with or without pertuzumab [IV, SC, or fixed-dose combination], or ado-trastuzumab emtansine, or neratinib) Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better History of persistent Grade ≥2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy History of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of Phesgo (Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of induction therapy). Treated with investigational therapy within 28 days prior to initiation of induction therapy Treated with localized palliative radiotherapy within 14 days prior to initiation of induction therapy Concurrent participation in any other therapeutic clinical trial Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent) Poorly controlled hypertension Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, active liver disease including active viral or other hepatitis virus, autoimmune hepatic disorders, or sclerosing cholangitis, current alcohol abuse, or cirrhosis Active cardiac disease or history of cardiac dysfunction Major surgical procedure or significant traumatic injury within 14 days prior to enrollment or anticipation of need for major surgery during induction therapy Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery Concurrent, serious, uncontrolled infections, or known infection with HIV with the following exception: Individuals who are HIV positive are eligible provided they are stable on anti-retroviral therapy for ≥4 weeks, have a CD4 count ≥350 cells/uL, and have an undetectable viral load and no history of AIDS-defining opportunistic infections within 12 months prior to enrollment. Serious COVID-19 infection within 14 days prior to enrollment; however, no screening testing for SARS-CoV-2 is required Serious infection requiring oral or IV antibiotics within 7 days prior to screening Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in the study History of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death For pre- and perimenopausal women, and men: Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa); Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy that requires gonadal function suppression Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm B A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism, including deep vein thrombosis, unless the condition is adequately treated and under control
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WO43571 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Name
Los Angeles Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
St Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256-6932
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Florida Cancer Specialists - EAST - SCRI - PPDS
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401-3406
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology - Annapolis
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Cancer Institute
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Individual Site Status
Recruiting
Facility Name
Hightower Clinical
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting
Facility Name
West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Cancer Institute - Edmonds Campus
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Cancer Institute - Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Individual Site Status
Recruiting
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Korben; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Scherbovsky
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
City
San Juan
ZIP/Postal Code
J5400DIL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Pronutrir - suporte nutricional e quimioterapia ltda.
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60810-180
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação Pio XII Hospital de Câncer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Hebei University; Department of medical oncology
City
Baoding
ZIP/Postal Code
071000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
the First Affiliated Hospital of Bengbu Medical College
City
Bengbu City
ZIP/Postal Code
233000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital - Sichuan University
City
Chengdu City
ZIP/Postal Code
610047
Country
China
Individual Site Status
Recruiting
Facility Name
No. 900 Hospital (Fuzhou General Hospital)
City
Fuzhou City
ZIP/Postal Code
350009
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People?s Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital Of Jinzhou Medical University
City
Jinzhou City
ZIP/Postal Code
121001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Yunnan Cancer Hospital
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Hospital of Nanchang
City
Nanchang City
ZIP/Postal Code
330009
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Cancer Hospital
City
Nanchang City
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Individual Site Status
Recruiting
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Liaoning Provincial Cancer Hospital
City
Shengyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Withdrawn
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang City
ZIP/Postal Code
110001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
The Tumor Hospital of Xinjiang Medical University
City
Urumqi
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xian Jiao Tong University
City
Xi'an City
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Clinica De La Costa
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
City
Bogota, D.C.
ZIP/Postal Code
110131
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
City
Bogota, D.C.
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Oncólogos de Occidente
City
Pereira
ZIP/Postal Code
600004
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Institut Sainte Catherine;Recherche Clinique
City
Avignon
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Name
CH de la Côte Basque - Hôpital de Bayonne
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de GRENOBLE
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Prive Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
INSTITUT CURIE_Site Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Catalan D' Oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Recruiting
Facility Name
Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim; Gynäkologie/ onkolog. Tagesklinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Individual Site Status
Recruiting
Facility Name
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gynäkologisches Zentrum Bonn
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Individual Site Status
Recruiting
Facility Name
Onkozentrum Dres. Göhler
City
Dresden
ZIP/Postal Code
01127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken Essen-Mitte
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Freiburg; Frauenklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
HOPA MVZ GmbH
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Individual Site Status
Recruiting
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dres. Andreas Köhler und Roswitha Fuchs
City
Langen
ZIP/Postal Code
63225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
City
Trier
ZIP/Postal Code
54290
Country
Germany
Individual Site Status
Recruiting
Facility Name
Budapesti Szent Margit Korhaz; Onkologia Osztaly
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephely
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz; Onkologiai Központ
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz; Onkologiai Osztaly
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Komarom-Eszergom Varmegyei Szent Borbala Korhaz; Onkologiai Osztaly
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Infermi AUSL della Romagna; U.O Operativa di Oncologia
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Humanitas Centro Catanese Di Oncologia; Oncologia Medica
City
Misterbianco (CT)
State/Province
Sicilia
ZIP/Postal Code
95045
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Civile; Unita Operativa Di Oncologia Medica
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
International Cancer Institute (ICI)
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Aga Khan University Hospital
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigacion Oncofarmaceutica
City
La Paz
State/Province
BAJA California SUR
ZIP/Postal Code
23040
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Iem-Fucam
City
D.f.
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
04980
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Filios Alta Medicina
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Universitario; Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Zambrano Hellion TecSalud
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
66278
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Cuidados oncologicos
City
Querétaro
State/Province
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oncologico Potosino
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Przychodnia Lekarska KOMED, Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Ars Medical Sp. z o. o.
City
Pi?a
ZIP/Postal Code
64-920
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
City
Pozna?
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
City
Rzeszow
ZIP/Postal Code
35-021
Country
Poland
Individual Site Status
Recruiting
Facility Name
IPO de Coimbra; Servico de Oncologia Medica
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de S. Francisco Xavier; Unidade de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1495-005
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Beatriz Angelo; Departamento de Oncologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Canarias;servicio de Oncologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital; Dept of Surgery
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital; Surgery
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital; Oncology
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center
City
Taipei 100
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taipei Veterans General Hospital Office of General Surgery
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ankara Oncology Hospital; Oncology
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi Uni Medical Faculty Hospital; Oncology Dept
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Uludag Uni Hospital; Oncology
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Uni Medical Faculty; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Katip Celebi University Ataturk Training and Research Hospital; Oncology
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Kocaeli University Faculty of Medicine; Medical oncology
City
Izmit
ZIP/Postal Code
31380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Erciyes Uni ; Medical Oncology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Antalya Memorial Hastanesi; Onkoloji
City
Kepez
ZIP/Postal Code
07020
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin City Education and Research Hospital
City
Mersin
ZIP/Postal Code
33240
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ac?badem Maslak Hastanesi Büyükdere
City
Sar?yer/?stanbul
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Medical Park Seyhan Hospital; Oncology Department
City
Seyhan
ZIP/Postal Code
01140
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
City
Tekirdag
ZIP/Postal Code
59030
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Karadeniz Tecnical University Medical Faculty; Oncology Department
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ac?badem Altunizade Hastanesi; Oncology
City
Üsküdar
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Recruiting
Facility Name
University Hospital North Tees
City
Cleveland
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Cornwall Hospital; Dept of Clinical Oncology
City
Cornwall
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Charing Cross Hospital; Medical Oncology.
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Maidstone Hospital; Kent Oncology Centre
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Preston Hosp; Rosemere Cancer Ctr
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen's Hospital; Oncology
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Singleton Hospital; Cancer Institute
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

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