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A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Primary Purpose

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Giredestrant

Giredestrant-matched Placebo

Letrozole

Letrozole-matched Placebo

Palbociclib

LHRH Agonist

About this trial

This is an interventional treatment trial for Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
Documented ER-positive tumor and HER2-negative tumor, assessed locally
Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
Eastern Cooperative Oncology Group Performance Status 0-1
Adequate organ function

Exclusion Criteria:

Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (AI)
Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
Prior treatment with a selective estrogen receptor degrader (SERD)
Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen
Treatment with any investigational therapy within 28 days prior to study treatment
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Active cardiac disease or history of cardiac dysfunction
Pregnant or breastfeeding

Sites / Locations

Long Beach Memorial Medical Center
Orange Coast Memorial Medical Center
Kaiser Permanente - San Leandro Medical Center
Stanford Univ Medical Center
Kaiser Permanente - Vallejo
Kaiser Permanente - Walnut Creek
University of Colorado
Rocky Mountain Cancer Center
Florida Cancer Specialists - Fort Myers (Broadway)
Memorial Regional Cancer Ctr
University of Miami; Dept Sylvester Cancer Center
SCRI Florida Cancer Specialists North; Research Office North Region.
SCRI Florida Cancer Specialists PAN
Kaiser Permanente - Moanalua Medical Center
Mercy Medical Center
Maryland Oncology Hematology; Maryland Oncology Hematology, PA
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
HCA Midwest Division
Memorial Sloan Kettering Cancer Center Basking Ridge
Astera Cancer Care East Brunswick
Memorial Sloan Kettering - Monmouth
Memorial Sloan Kettering Cancer Center at Bergen
San Juan Oncology Associates
MSKCC @ Commack
Memorial Sloan Kettering Cancer Center at Westchester
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
Mount Sinai West
Mount Sinai School of Medicine; Mount Sinai Hospital
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center at Nassau
Fairview Hospital; Cleveland Clinic Cancer Center
The Cleveland Clinic Foundation
Hillcrest Hospital; Hirsch Cancer Center
Strongsville Hospital; Cleveland Clinic Cancer Center
Providence Portland Medical Ctr
Roper St. Francis Healthcare
West Cancer Center
Sarah Cannon Research Inst.
Harrington Cancer Center
Texas Oncology-Baylor Sammons Cancer Center
Renovatio Clinical - El Paso
Texas Oncology, P.A. - Fort Worth
The Center for Cancer and Blood Disorders - Fort Worth
Baylor St. Luke's Medical Center
Houston Methodist Hospital
Renovatio Clinical
Inova Fairfax Hospital
Virginia Oncology Associates
Northwest Medical Specialties
University of Wisconsin
Fundación CENIT para la Investigación en Neurociencias
Hospital Britanico
Organización medica de Investi
Hospital de Onc Angel Roffo
Instituto de Oncología de Rosario
Hospital Provincial del Centenario
CEMER Centro Medico de Enfermedades Respiratorias
Calvary Mater Newcastle; Medical Oncology
Mater Hospital Brisbane
Princess Alexandra Hospital; Division of Cancer Services
Flinders Medical Centre; Medical Oncology
Peter MacCallum Cancer Centre-East Melbourne
Sunshine Hospital
Fiona Stanley Hospital - Medical Oncology
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Cliniques Universitaires St-Luc
Jessa Zkh (Campus Virga Jesse)
Hospital Sao Rafael - HSR
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Hospital do Cancer de Pernambuco - HCP
Santa Casa de Misericordia de Porto Alegre
Hospital Sao Lucas - PUCRS
Hospital de Base de Sao Jose do Rio Preto
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Beneficencia Portuguesa de Sao Paulo
Tom Baker Cancer Centre-Calgary
BC Cancer ? Surrey
Royal Victoria Regional Health Centre
William Osler Health System Brampton Civic Hospital
Ottawa Hospital Research Institute
Princess Margaret Cancer Center
Universite de Montreal - Hopital Maisonneuve-Rosemont
Centre Hospitalier de l?Université de Montréal (CHUM)
Jewish General Hospital
McGill University Health Center
Hopital du Saint Sacrement
Anyang Tumor Hosptial
Affiliated Hospital of Hebei University; Department of medical oncology
Peking University People's Hospital
Beijing Cancer Hospital
the First Affiliated Hospital of Bengbu Medical College
The First Hospital of Jilin University
Hunan Cancer Hospital
Fujian Medical University Union Hospital
Sun Yet-sen University Cancer Center
Sun Yat-sen Memorial Hospital
Sir Run Run Shaw Hospital Zhejiang University
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Harbin Medical University Cancer Hospital
Shandong Cancer Hospital
The Third Hospital of Nanchang
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Guangxi Cancer Hospital of Guangxi Medical University
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Cancer Hospital of Shantou University Medical College
Shengjing Hospital of China Medical University
Liaoning cancer Hospital & Institute
Weifang People's Hospital
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Hubei Cancer Hospital
The First Affiliated Hospital of Xian Jiao Tong University
Herlev Hospital; Afdeling for Kræftbehandling
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
Odense Universitetshospital, Onkologisk Afdeling R
ICO Paul Papin; Oncologie Medicale.
Centre Hospitalier de La Cote Basque; Oncologie
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie
CENTRE HOSPITALIER EMILE ROUX; ONCOLOGIE et CHIMIOTHERAPIE
Institut régional du Cancer Montpellier
Chu La Miletrie; Oncologie Medicale
Institut Jean Godinot; Oncologie Medicale
Centre Eugene Marquis; Service d'oncologie
ICL; Hematologie
Centre Alexis Vautrin; Oncologie Medicale
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Dres.Andreas Ammon und Dirk Meyer
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Facharztzentrum Eppendorf, Studien GbR
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
Dres. Andreas Köhler und Roswitha Fuchs
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
Universitätsklinikum Mannheim; Frauenklinik
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Universitätsklinik Tübingen; Frauenklinik
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
University Hospital of Larissa;Department of Medical Oncology
Euromedical General Clinic of Thessaloniki; Oncology Department
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Princess Margaret Hospital; Oncology
Queen Mary Hospital; Dept of Medicine
Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department
Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály
Davidof Center - Rabin Medical Center
Chaim Sheba Medical Center; Oncology Dept
Tel Aviv Sourasky Medical Ctr; Oncology
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Istituto Europeo Di Oncologia
ASST DI MONZA; Oncologia Medica
Fondazione del Piemonte per l?Oncologia (IRCCS)
Humanitas Centro Catanese Di Oncologia; Oncologia Medica
Ospedale Civile - Livorno
Ospedale Sacro Cuore Don Calabria
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
Nagoya University Hospital
Chiba Cancer Center
National Cancer Center Hospital East
National Hospital Organization Kyushu Cancer Center
Fukushima Medical University Hospital
Hiroshima City Hiroshima Citizens Hospital
Hiroshima University Hospital
National Hospital Organization Hokkaido Cancer Center
Hyogo Cancer Center
University of Tsukuba Hospital
Sagara Hospital
St. Marianna University Hospital
Kanagawa Cancer Center
Tokai University Hospital
Kumamoto University Hospital
Niigata Cancer Center Hospital
Naha-nishi Clinic
National Hospital Organization Osaka National Hospital
Osaka International Cancer Institute
Saitama Cancer Center
National Cancer Center Hospital
St. Luke's Internat. Hospital, Breast Surgical Oncology
Juntendo University Hospital
The Cancer Institute Hospital of JFCR
Showa University Hospital
Chungbuk National University Hospital
Kyungpook National University Medical Center
National Cancer Center
Gachon University Gil Medical Center
Seoul National University Bundang Hospital
Korea University Anam Hospital
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
Asan Medical Center
Gangnam Severance Hospital
Korea University Guro Hospital
Samsung Medical Center
Ulsan University Hosiptal
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Health Pharma Professional Research
Centro Medico Dalinde
Filios Alta Medicina
Centro de Investigacion Clinica de Oaxaca
Oncologico Potosino
Sociedad de Metabolismo y Corazón (SOMECO)
Auckland City Hospital; Clinical Oncology
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
Oncosalud Sac; Oncología
Instituto Peruano de Oncología y Radioterapia
Instituto Nacional de Enfermedades Neoplasicas
Clinica Ricardo Palma
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Szpital Morski im. PCK; Poradnia Onkologiczna
Woj. Wielospecjalistyczne Centrum Onkol. i Traumat. im.M.Kopernika; Woj. Przychodnia Onkologiczna
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
IPO de Coimbra; Servico de Oncologia Medica
Hospital da Luz; Departamento de Oncologia Medica
Centro Hospitalar Lisboa Norte
IPO do Porto; Servico de Oncologia Medica
Respublikanskiy Onkologicheskiy Dispanser
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Podolsk City Clinical Hospital; Hematology
Ryazan Regional clinical oncology dispensary
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Chelyabinsk region oncology dispensary
Multidisciplinary clinic Reaviz
Regional Clinical Oncology Hospital
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Hospital de Donostia; Servicio de Oncologia Medica
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
Hospital Quiron de Madrid; Servicio de Oncologia
Hospital del Mar; Servicio de Oncologia
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Hospital Duran i Reynals; Oncologia
Hospital Lucus Augusti; Servicio de Oncologia
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Hospital Ramon y Cajal; Servicio de Oncologia
Hospital Clinico San Carlos; Servicio de Oncologia
HM Sanchinarro ? CIOCC; Servicio de Oncologia
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
China Medical University Hospital; Surgery
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
VETERANS GENERAL HOSPITAL; Department of General Surgery
National Taiwan Uni Hospital; Dept of Oncology
Mackay Memorial Hospital; Dept of Surgery
Chang Gung Memorial Hosipital at Linkou
Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine
Rajavithi Hospital; Division of Medical Oncology
Ramathibodi Hospital; Medicine/Oncology
Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
Songklanagarind Hospital; Department of Oncology
Adana Baskent University Hospital; Medical Oncology
Ankara Bilkent City Hospital
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Medipol University Medical Faculty; Oncology Department
Katip Celebi University Ataturk Training and Research Hospital; Oncology
Kocaeli University Faculty of Medicine; Medical oncology
Medeniyet University Goztepe Training and Research Hospital.
Antalya Memorial Hastanesi; Onkoloji
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Mersin Medical Park Hospital
19 Mayis University Medical Faculty; Medical Oncology Department
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Municipal Institution City Clinical Hospital #4 of Dnipro City Council
Uzhgorod Central City Clinical Hospital
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
Ivano-Frankivsk Regional Oncology Center
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
Sumy Regional Clinical Onc Ctr
Royal Sussex County Hospital
Velindre Cancer Centre; Clinical Trials Unit
Leicester Royal Infirmary; Infectious Disease Unit
University College London Hospital
Royal Free Hospital
Guys & St Thomas Hospital; Department of Oncology
Royal Marsden Hosp NHS Fnd; Breast Unit
Maidstone Hospital; Kent Oncology Centre
Nottingham City Hospital
Peterborough City Hospital; Oncology Research Department 018
Derriford Hospital
Royal Stoke University Hospital
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Giredestrant + Letrozole-matched Placebo + Palbociclib

Letrozole + Giredestrant-matched Placebo + Palbociclib

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS), 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 or partial response 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 or partial response.

Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire

Time to Confirmed Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score

EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire

Time to Confirmed Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score

Time to Confirmed Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score

Time to Confirmed Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score

Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)

Number of Participants with Vital Sign Abnormalities Over the Course of the Study

Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.

Plasma Concentration of Giredestrant at Specified Timepoints

Plasma Concentration of Palbociclib at Specified Timepoints

Full Information

NCT ID

NCT04546009

First Posted

September 8, 2020

Last Updated

August 21, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT04546009

Brief Title

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Official Title

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 9, 2020 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

March 18, 2027 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

992 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Giredestrant + Letrozole-matched Placebo + Palbociclib

Arm Type

Experimental

Arm Title

Letrozole + Giredestrant-matched Placebo + Palbociclib

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Giredestrant

Other Intervention Name(s)

GDC-9545, RO7197597, RG6171

Intervention Description

Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Giredestrant-matched Placebo

Intervention Description

Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Letrozole

Intervention Description

Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Letrozole-matched Placebo

Intervention Description

Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Palbociclib

Intervention Description

Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

LHRH Agonist

Intervention Description

Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Primary Outcome Measure Information:

Title

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

Time Frame

From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

From randomization to death from any cause (up to 78 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 or partial response on two consecutive occasions at least (≥)4 weeks apart.

Time Frame

From randomization until disease progression or death (up to 78 months)

Title

Duration of Response, as Determined by the Investigator According to RECIST v1.1

Time Frame

From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 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 or partial response.

Time Frame

From randomization until disease progression or death (up to 78 months)

Title

Time Frame