Back to resultsA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inavolisib
Phesgo
Placebo
Taxane-based Chemotherapy
Optional Endocrine Therapy of Investigator's Choice
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria: Prior treatment in the 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 Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy History or active inflammatory bowel disease Disease progression within 6 months of receiving any HER2-targeted therapy Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis Symptomatic active lung disease, including pneumonitis or interstitial lung disease Any history of leptomeningeal disease or carcinomatous meningitis Serious infection requiring IV antibiotics 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
Sites / Locations
- Lawrence J. Ellison Institute for Transformative MedicineRecruiting
- Georgetown Uni Hospital; 4-N Main HospitalRecruiting
- Medstar Research InstituteRecruiting
- Dana Farber Cancer InstituteRecruiting
- Hightower ClinicalRecruiting
- Lumi ResearchRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Fundación CENIT para la Investigación en NeurocienciasRecruiting
- Centro Oncologico Korben; OncologyRecruiting
- Instituto de Oncología de RosarioRecruiting
- Kinghorn Cancer Centre; St Vincents HospitalRecruiting
- University of the Sunshine CoastRecruiting
- Sir Charles Gairdner Hospital; Medical OncologyRecruiting
- Hospital do Cancer de Pernambuco - HCPRecruiting
- Hospital do Câncer de LondrinaRecruiting
- Santa Casa de Misericordia de Porto AlegreRecruiting
- Hospital Sao Lucas - PUCRSRecruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting
- Jewish General HospitalRecruiting
- Hopital du Saint SacrementRecruiting
- Affiliated Hospital of Hebei University; Department of medical oncologyRecruiting
- Beijing Cancer HospitalRecruiting
- The First Hospital of Jilin UniversityRecruiting
- Sichuan Provincial People's HospitalRecruiting
- Fujian Cancer HospitalRecruiting
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Zhejiang Cancer Hospital; Breast SurgeryRecruiting
- Harbin Medical University Tumor Hospital; Department of Surgery; PharmacyRecruiting
- Shandong Cancer HospitalRecruiting
- The First Affiliated Hospital to Henan University of Science and TechnologyRecruiting
- The Second Affiliated Hospital to Nanchang UniversityRecruiting
- Shantou Center HospitalRecruiting
- Tianjin Cancer Hospital; Department of Breast OncologyRecruiting
- Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
- Hubei Cancer HospitalRecruiting
- National Cancer CenterRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Gangnam Severance HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul St Mary's HospitalRecruiting
- National Cancer Centre; Medical OncologyRecruiting
- Limpopo Oncology ClinicRecruiting
- National Taiwan Uni Hospital; General SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Active Comparator
Arm Label
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Maintenance Therapy: Inavolisib plus Phesgo
Maintenance Therapy: Placebo plus Phesgo
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.
Participants will be administered the treatments as outlined in the interventions section.
Outcomes
Primary Outcome Measures
Investigator-Assessed Progression-Free Survival (PFS)
Secondary Outcome Measures
Overall Survival (OS)
Investigator-Assessed Objective Response Rate (ORR)
Investigator-Assessed Duration of Response (DOR)
Investigator-Assessed Clinical Benefit Rate (CBR)
Investigator-Assessed PFS2
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)
Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Percentage of Participants with Adverse Events
Plasma Concentration of Inavolisib at Specified Timepoints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05894239
Brief Title
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Official Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-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 28, 2023 (Actual)
Primary Completion Date
October 31, 2028 (Anticipated)
Study Completion Date
October 31, 2028 (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 study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Arm Type
Other
Arm Description
Participants will be administered the treatments as outlined in the interventions section.
Arm Title
Maintenance Therapy: Inavolisib plus Phesgo
Arm Type
Experimental
Arm Description
Participants will be administered the treatments as outlined in the interventions section.
Arm Title
Maintenance Therapy: Placebo plus Phesgo
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 receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
Intervention Type
Drug
Intervention Name(s)
Phesgo
Intervention Description
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Intervention Type
Drug
Intervention Name(s)
Taxane-based Chemotherapy
Other Intervention Name(s)
non-investigational medicinal product (NIMP)
Intervention Description
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Intervention Type
Drug
Intervention Name(s)
Optional Endocrine Therapy of Investigator's Choice
Other Intervention Name(s)
NIMP
Intervention Description
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI [anastrozole, letrozole, or exemestane]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Primary Outcome Measure Information:
Title
Investigator-Assessed Progression-Free Survival (PFS)
Time Frame
Up to approximately 40 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to approximately 111 months
Title
Investigator-Assessed Objective Response Rate (ORR)
Time Frame
Up to approximately 111 months
Title
Investigator-Assessed Duration of Response (DOR)
Time Frame
Up to approximately 111 months
Title
Investigator-Assessed Clinical Benefit Rate (CBR)
Time Frame
Up to approximately 111 months
Title
Investigator-Assessed PFS2
Time Frame
Up to approximately 111 months
Title
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)
Description
Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
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 every 6 months (up to 111 months). Each cycle is 21 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 111 months). Each cycle is 21 days.
Title
Plasma Concentration of Inavolisib at Specified Timepoints
Time Frame
Day 1 of Cycles 1 and 4. Each cycle is 21 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months
LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
Adequate hematologic and organ function prior to initiation of study treatment
Exclusion Criteria:
Prior treatment in the 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
Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
History or active inflammatory bowel disease
Disease progression within 6 months of receiving any HER2-targeted therapy
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Symptomatic active lung disease, including pneumonitis or interstitial lung disease
Any history of leptomeningeal disease or carcinomatous meningitis
Serious infection requiring IV antibiotics 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WO44263 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
Lawrence J. Ellison Institute for Transformative Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown Uni Hospital; 4-N Main Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Medstar Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20783
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
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
Recruiting
Facility Name
Centro Oncologico Korben; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426AGE
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
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
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
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
Hospital do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital do Câncer de Londrina
City
Londrina
State/Province
PR
ZIP/Postal Code
86015-520
Country
Brazil
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 Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
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
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
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
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
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
Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610072
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou City
ZIP/Postal Code
310009
Country
China
Individual Site Status
Withdrawn
Facility Name
Zhejiang Cancer Hospital; Breast Surgery
City
Hangzhou City
ZIP/Postal Code
310022
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 First Affiliated Hospital to Henan University of Science and Technology
City
Luoyang City
ZIP/Postal Code
471031
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
Shantou Center Hospital
City
Shantou City
ZIP/Postal Code
515031
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
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
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
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Limpopo Oncology Clinic
City
Polokwane
ZIP/Postal Code
0700
Country
South Africa
Individual Site Status
Recruiting
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
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/innovation/process/clinical-trials/data-sharing/).
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
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