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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

Purpose

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).

Condition

Metastatic Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Other Induction Therapy: Phesgo plus Taxane-Based Chemotherapy	Participants will be administered the treatments as outlined in the interventions section.	Drug: Phesgo Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle. Drug: Taxane-based Chemotherapy During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo. Other names: non-investigational medicinal product (NIMP)
Experimental Maintenance Therapy: Inavolisib plus Phesgo	Participants will be administered the treatments as outlined in the interventions section.	Drug: Inavolisib 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. Drug: Phesgo Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle. Drug: Optional Endocrine Therapy of Investigator's Choice 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. Other names: NIMP
Active Comparator Maintenance Therapy: Placebo plus Phesgo	Participants will be administered the treatments as outlined in the interventions section.	Drug: Phesgo Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle. Drug: Placebo Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment. Drug: Optional Endocrine Therapy of Investigator's Choice 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. Other names: NIMP

Recruiting Locations

Georgetown Uni Hospital; 4-N Main Hospital
Washington, District of Columbia 20007

Medstar Research Institute
Hyattsville, Maryland 20783

More Details

Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: WO44263 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.