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A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inavolisib
Fulvestrant
Alpelisib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria: If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1 Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 Life expectancy of > 6 months Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria: Metaplastic breast cancer Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway Participant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes Inability or unwillingness to swallow pills Malabsorption syndrome or other condition that would interfere with enteral absorption Any history of leptomeningeal disease or carcinomatous meningitis Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1 Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye Requirement for daily supplemental oxygen Symptomatic active lung disease, including pneumonitis History of or active inflammatory bowel disease Any active bowel inflammation Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis Participants with known human immunodeficiency virus infection that meet specific criteria Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence Chronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms Active ongoing osteonecrosis of the jaw

Sites / Locations

  • Cancer Blood and Specialty ClinicRecruiting
  • Los Angeles Cancer NetworkRecruiting
  • University of California, Irvine Medical CenterRecruiting
  • Eastern CT Hematology and Oncology AssociatesRecruiting
  • Cancer Care Centers of BrevardRecruiting
  • Minnesota Oncology HematologyRecruiting
  • Gabrail Cancer CenterRecruiting
  • Asante Rogue Regional Medical CenterRecruiting
  • Consultants in Medical Oncology and Hematology
  • Abramson Cancer Center Chester County Hospital; Hematology, Medical OncologyRecruiting
  • Texas Oncology WestRecruiting
  • Texas Oncology - Dallas Presbyterian HospitalRecruiting
  • Texas Tech University Health Sciences Center; Department of Internal MedicineRecruiting
  • Texas Oncology (Flower Mound) - USORRecruiting
  • The Center for Cancer and Blood Disorders - Fort WorthRecruiting
  • Lumi ResearchRecruiting
  • Texas Oncology McKinneyRecruiting
  • Kadlec Clinic Hematology and OncologyRecruiting
  • Fundación CENIT para la Investigación en Neurociencias
  • Centro Oncologico Korben; OncologyRecruiting
  • Fundacion CORI para la Investigacion y Prevencion del CancerRecruiting
  • Instituto de Oncología de RosarioRecruiting
  • Sanatorio Parque S.A.Recruiting
  • Clinica Viedma S.A.Recruiting
  • Coffs Harbour Health CampusRecruiting
  • Concord Repatriation General Hospital; Concord Cancer CentreRecruiting
  • Kinghorn Cancer Centre; St Vincents HospitalRecruiting
  • Gosford Hospital; Cancer Care ServicesRecruiting
  • Icon Cancer Care WesleyRecruiting
  • University of the Sunshine CoastRecruiting
  • Bendigo Cancer CentreRecruiting
  • Sir Charles Gairdner Hospital; Medical OncologyRecruiting
  • Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital de Base de Sao Jose do Rio PretoRecruiting
  • BC Cancer ? VancouverRecruiting
  • The Moncton HospitalRecruiting
  • Juravinski HospitalRecruiting
  • The Ottawa Hospital - General CampusRecruiting
  • CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-RosemontRecruiting
  • Centre Hospitalier de l'Universite de Montreal (CHUM)Recruiting
  • Jewish General HospitalRecruiting
  • Hôpital du Sacré-Coeur de MontrealRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Sichuan Provincial Cancer HospitalRecruiting
  • Guangdong Provincial People's Hospital; BreastRecruiting
  • Sun yat-sen University Cancer Center; Internal Medicine of OncologyRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Sir Run Run Shaw Hospital Zhejiang UniversityRecruiting
  • Harbin Medical University Tumor Hospital; Department of Surgery; PharmacyRecruiting
  • Shandong Cancer HospitalRecruiting
  • The Second Affiliated Hospital to Nanchang UniversityRecruiting
  • Jiangsu Cancer HospitalRecruiting
  • Tianjin Cancer Hospital; Department of Breast OncologyRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Hubei Cancer HospitalRecruiting
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong UniversityRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • National Cancer CenterRecruiting
  • CHA Bundang Medical CenterRecruiting
  • Catholic Univ. of Incheon St.Mary's HospitalRecruiting
  • Inha University HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St Mary's HospitalRecruiting
  • Antiguo Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
  • Health Pharma Professional ResearchRecruiting
  • COI Centro Oncologico Internacional Santa FeRecruiting
  • OncoMed; Supportive CareRecruiting
  • ARKE Estudios Clínicos S.A. de C.V.Recruiting
  • Instituto Nacional de Cancerologia; OncologyRecruiting
  • ICO L'Hospitalet; Servicio de oncologia medicaRecruiting
  • Hospital Ramon y Cajal; Servicio de OncologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
  • Hospital Universitario Virgen de Arrixaca; Servicio de OncologiaRecruiting
  • Hospital Universitario Virgen Macarena; Servicio de OncologiaRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Memorial Hosipital at LinkouRecruiting
  • Veterans General Hospital - TaichungRecruiting
  • National Taiwan University Hospital; OncologyRecruiting
  • Gulhane Training and Applicaton HospitalRecruiting
  • Memorial Ankara HastanesiRecruiting
  • Dicle University Faculty of MedicineRecruiting
  • Trakya University Medical FacultyRecruiting
  • Medipol Mega Üniversite Hastanesi GöztepeRecruiting
  • Marmara Uni Faculty of Medicine; Medical OncologyRecruiting
  • Ege Uni Medical Faculty Hospital; Oncology DeptRecruiting
  • Katip Celebi University Ataturk Training and Research Hospital; OncologyRecruiting
  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical OncologyRecruiting
  • Hacettepe Uni Medical Faculty Hospital; Oncology DeptRecruiting
  • Basingstoke and North Hampshire HospitalRecruiting
  • Blackpool Victoria HospitalRecruiting
  • Western General Hospital; Clinical OncologyRecruiting
  • Princess Alexandra HospitalRecruiting
  • Maidstone & Tonbridge Wells Hospital; Kent Oncology CenterRecruiting
  • Mount Vernon & Watford Trust Hospital; Dept. of Clinical OncologyRecruiting
  • Churchill Hospital; Department of OncologyRecruiting
  • ROYAL HAMPSHIRE COUNTY HOSPITAL; R&D OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inavolisib + Fulvestrant

Alpelisib + Fulvestrant

Arm Description

Participants will be administered the treatments as outlined in the interventions section.

Participants will be administered the treatments as outlined in the interventions section.

Outcomes

Primary Outcome Measures

Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)

Secondary Outcome Measures

Overall survival (OS)
BICR-Assessed Overall Response Rate (ORR)
BICR-Assessed Best Overall Response (BOR)
BICR-Assessed Clinical Benefit Rate (CBR)
BICR-Assessed Duration of Response (DOR)
Time to Confirmed Deterioration (TTCD) in Pain
TTCD in Physical Functioning
TTCD in Role Functioning
TTCD in Global Health Status/Quality of Life (QOL)
Percentage of Participants with Adverse Events
Plasma Concentration of Inavolisib at Specified Timepoints

Full Information

First Posted
December 2, 2022
Last Updated
October 12, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05646862
Brief Title
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Acronym
INAVO121
Official Title
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
March 30, 2029 (Anticipated)
Study Completion Date
March 30, 2029 (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 is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Inavolisib + Fulvestrant
Arm Type
Experimental
Arm Description
Participants will be administered the treatments as outlined in the interventions section.
Arm Title
Alpelisib + Fulvestrant
Arm Type
Active Comparator
Arm Description
Participants will be administered the treatments as outlined in the interventions section.
Intervention Type
Drug
Intervention Name(s)
Inavolisib
Intervention Description
Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Alpelisib
Intervention Description
Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.
Primary Outcome Measure Information:
Title
Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)
Time Frame
From randomization until disease progression or death due to any cause (up to approximately 64 months)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
From randomization until death due to any cause (up to approximately 85 months)
Title
BICR-Assessed Overall Response Rate (ORR)
Time Frame
Up to approximately 64 months
Title
BICR-Assessed Best Overall Response (BOR)
Time Frame
Up to approximately 64 months
Title
BICR-Assessed Clinical Benefit Rate (CBR)
Time Frame
Up to approximately 64 months
Title
BICR-Assessed Duration of Response (DOR)
Time Frame
From CR or PR until disease progression or death due to any cause (up to approximately 64 months)
Title
Time to Confirmed Deterioration (TTCD) in Pain
Time Frame
Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Title
TTCD in Physical Functioning
Time Frame
Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Title
TTCD in Role Functioning
Time Frame
Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Title
TTCD in Global Health Status/Quality of Life (QOL)
Time Frame
Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Title
Percentage of Participants with Adverse Events
Time Frame
Day 1 until 30 days after the final dose of study treatment (up to approximately 85 months)
Title
Plasma Concentration of Inavolisib at Specified Timepoints
Time Frame
Day 1 and 15 of Cycle 1, and Day 1 of Cycles 2 and 3. Each cycle is 28 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1 Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 Life expectancy of > 6 months Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria: Metaplastic breast cancer Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway Participant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes Inability or unwillingness to swallow pills Malabsorption syndrome or other condition that would interfere with enteral absorption Any history of leptomeningeal disease or carcinomatous meningitis Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1 Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye Requirement for daily supplemental oxygen Symptomatic active lung disease, including pneumonitis History of or active inflammatory bowel disease Any active bowel inflammation Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis Participants with known human immunodeficiency virus infection that meet specific criteria Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence Chronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms Active ongoing osteonecrosis of the jaw
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WO43919 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
Cancer Blood and Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Los Angeles Cancer Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017-4803
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360-2740
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Centers of Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Oncology Hematology
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Asante Rogue Regional Medical Center
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-8332
Country
United States
Individual Site Status
Recruiting
Facility Name
Consultants in Medical Oncology and Hematology
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Individual Site Status
Withdrawn
Facility Name
Abramson Cancer Center Chester County Hospital; Hematology, Medical Oncology
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology West
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Tech University Health Sciences Center; Department of Internal Medicine
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology (Flower Mound) - USOR
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Individual Site Status
Recruiting
Facility Name
The Center for Cancer and Blood Disorders - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336-7774
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
Active, not recruiting
Facility Name
Centro Oncologico Korben; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion CORI para la Investigacion y Prevencion del Cancer
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Parque S.A.
City
Rosario
ZIP/Postal Code
S2000QGB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Viedma S.A.
City
Viedma
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Individual Site Status
Recruiting
Facility Name
Concord Repatriation General Hospital; Concord Cancer Centre
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Kinghorn Cancer Centre; St Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gosford Hospital; Cancer Care Services
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Care Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Name
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Individual Site Status
Recruiting
Facility Name
Bendigo Cancer Centre
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital; Medical Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
BC Cancer ? Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hôpital du Sacré-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
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
Sichuan Provincial Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital; Breast
City
Guangzhou City
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
Sun yat-sen University Cancer Center; Internal Medicine of Oncology
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou City
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
City
Harbin
ZIP/Postal Code
150049
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital to Nanchang University
City
Nanchang
ZIP/Postal Code
330006
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
Tianjin Cancer Hospital; Department of Breast Oncology
City
Tianjin
ZIP/Postal Code
300000
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
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
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
Recruiting
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Catholic Univ. of Incheon St.Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
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
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
Antiguo 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
COI Centro Oncologico Internacional Santa Fe
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
01330
Country
Mexico
Individual Site Status
Recruiting
Facility Name
OncoMed; Supportive Care
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
ARKE Estudios Clínicos S.A. de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancerologia; Oncology
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
ICO L'Hospitalet; Servicio de oncologia medica
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hosipital at Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Veterans General Hospital - Taichung
City
Xitun Dist.
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital; Oncology
City
Zhongzheng Dist.
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Gulhane Training and Applicaton Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol Mega Üniversite Hastanesi Göztepe
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara Uni Faculty of Medicine; Medical Oncology
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Uni Medical Faculty Hospital; 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
Recruiting
Facility Name
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
City
Kadiköy
ZIP/Postal Code
34722
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
Recruiting
Facility Name
Basingstoke and North Hampshire Hospital
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Western General Hospital; Clinical Oncology
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Churchill Hospital; Department of Oncology
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
ROYAL HAMPSHIRE COUNTY HOSPITAL; R&D Office
City
Winchester
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data 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 the Sharing of Clinical 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 Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

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