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Inavolisib and Phesgo for HER2-Positive Metastatic Breast Cancer

This study is looking at a new treatment approach for people with HER2-positive metastatic breast cancer that has a specific change in a gene called PIK3CA. You might be able to join if you have HER2-positive breast cancer that has spread or is locally advanced, and you haven't had treatment for it yet. The study will compare a drug called inavolisib combined with Phesgo (a combination of pertuzumab, trastuzumab, and rHuPH20) against Phesgo alone. Phesgo is given as an injection under the skin, and inavolisib is a tablet taken by mouth. The main goal is to see if the inavolisib combination helps people live longer without their cancer getting worse. The study plans to enroll about 230 participants.

Study design
This interventional study will compare two treatment groups, with participants receiving either inavolisib plus Phesgo or a placebo plus Phesgo. It aims to enroll 230 participants.
What's involved
Participants will receive Phesgo injections every three weeks and take inavolisib or a placebo tablet daily for 21 days of each 21-day cycle. You will also receive taxane-based chemotherapy during an initial treatment phase.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 40 months to track how long they live without their cancer progressing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Hoffmann-La Roche
~230 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:InavolisibPhesgoPlaceboTaxane-based ChemotherapyOptional Endocrine Therapy of Investigator's Choice

At a glance

Recruiting sites
99 of 192 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigator-Assessed Progression-Free Survival (PFS)
Measured over Up to approximately 40 months

Conditions

Metastatic Breast Cancer

Explore related trials

Breast CarcinomaPIK3CA Gene

Where it's being run

192 sites across 70 states
China16
Germany12
Japan9
Turkey (Türkiye)9
Belgium8
Poland8
South Korea7
Spain7

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WO44263 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Investigator-Assessed Progression-Free Survival (PFS)Up to approximately 40 months