Recruiting NCT05894239

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 III Interventional Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy.
Who it may be relevant to: Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +24
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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).

Interventions

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 Placebo
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Drug Taxane-based Chemotherapy
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
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

Primary outcome measures

Investigator-Assessed Progression-Free Survival (PFS) [Time frame: Up to approximately 40 months]

Secondary outcome measures (8)

Overall Survival (OS) [Time frame: Up to approximately 111 months]
Investigator-Assessed Objective Response Rate (ORR) [Time frame: Up to approximately 111 months]
Investigator-Assessed Duration of Response (DOR) [Time frame: Up to approximately 111 months]
Investigator-Assessed Clinical Benefit Rate (CBR) [Time frame: Up to approximately 111 months]
Investigator-Assessed PFS2 [Time frame: Up to approximately 111 months]
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL) [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.]
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.]
Plasma Concentration of Inavolisib at Specified Timepoints [Time frame: Day 1 of Cycles 1 and 4. Each cycle is 21 days.]

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
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 20 centers

Banner Health MD Anderson AZ — Gilbert
Disney Family Cancer Center — Burbank
City of Hope — Corona
City of Hope Comprehensive Cancer Center — Duarte
City of Hope at Irvine Lennar — Irvine
Ellison Institute of Technology — Los Angeles
Georgetown Uni Hospital — Washington D.C.
Medstar Research Institute — Hyattsville
… and 12 more centers

China · 16 centers

Affiliated Hospital of Hebei University — Baoding
Beijing Cancer Hospital — Beijing
The First Hospital of Jilin University — Changchun
Sichuan Provincial Cancer Hospital — Chengdu
Sichuan Provincial People's Hospital — Chengdu
Fujian Cancer Hospital — Fuzhou
Zhejiang Cancer Hospital — Hangzhou
Harbin Medical University Tumor Hospital — Harbin
… and 8 more centers

Germany · 12 centers