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
Phase 3
Recruiting
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: Taxane-based ChemotherapyDrug: PlaceboDrug: Optional Endocrine Therapy of Investigator's Choice
- Registration Number
- NCT05894239
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
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
- Participants with active HBV infection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Induction Therapy: Phesgo plus Taxane-Based Chemotherapy Phesgo Participants will be administered the treatments as outlined in the interventions section. Induction Therapy: Phesgo plus Taxane-Based Chemotherapy Taxane-based Chemotherapy Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Inavolisib plus Phesgo Inavolisib Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Inavolisib plus Phesgo Phesgo Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Inavolisib plus Phesgo Optional Endocrine Therapy of Investigator's Choice Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Placebo plus Phesgo Phesgo Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Placebo plus Phesgo Placebo Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Placebo plus Phesgo Optional Endocrine Therapy of Investigator's Choice Participants will be administered the treatments as outlined in the interventions section.
- Primary Outcome Measures
Name Time Method Investigator-Assessed Progression-Free Survival (PFS) Up to approximately 40 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 111 months Investigator-Assessed Objective Response Rate (ORR) Up to approximately 111 months Investigator-Assessed Duration of Response (DOR) Up to approximately 111 months Investigator-Assessed Clinical Benefit Rate (CBR) Up to approximately 111 months Investigator-Assessed PFS2 Up to approximately 111 months Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL) 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. 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 Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days. Plasma Concentration of Inavolisib at Specified Timepoints Day 1 of Cycles 1 and 4. Each cycle is 21 days.
Trial Locations
- Locations (173)
Banner Health MD Anderson AZ
🇺🇸Gilbert, Arizona, United States
Disney Family Cancer Center
🇺🇸Burbank, California, United States
Ellison Institute of Technology
🇺🇸Los Angeles, California, United States
Georgetown Uni Hospital
🇺🇸Washington, District of Columbia, United States
Medstar Research Institute
🇺🇸Hyattsville, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
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