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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

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).

Key facts

Study ID

NCT05894239

Run by

Hoffmann-La Roche

People needed

230

Starts

2023-09-08

Expected to finish

2032-12-28

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital do Câncer de Londrina — Londrina, Paraná, Brazil (enrolling)
• Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil (enrolling)
• Banner Health MD Anderson AZ — Gilbert, Arizona, United States (enrolling)
• Hospital Araujo Jorge — Goiânia, Goiás, Brazil (enrolling)
• Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Hospital de Amor Amazônia — Porto Velho, Rondônia, Brazil (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Disney Family Cancer Center — Burbank, California, United States (enrolling)
• Hospital Sao Rafael - HSR — Salvador, Estado de Bahia, Brazil (enrolling)
• Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco, Brazil (enrolling)
• Atrium Health — Charlotte, North Carolina, United States (enrolling)
• Georgetown Uni Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Renovatio Clinical - El Paso — El Paso, Texas, United States (enrolling)
• JPS Health Network — Fort Worth, Texas, United States (enrolling)
• Medstar Research Institute — Hyattsville, Maryland, United States (enrolling)
• Renovatio Clinical — The Woodlands, Texas, United States (enrolling)
• Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
• Crio - Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil (enrolling)
• Ellison Institute of Technology — Los Angeles, California, United States (enrolling)
• City of Hope — Corona, California, United States (enrolling)
• Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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