OncoMatch/Clinical Trials/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
Is NCT05894239 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Inavolisib and Phesgo for metastatic breast cancer.
Treatment: Inavolisib · Phesgo · Taxane-based Chemotherapy · Optional Endocrine Therapy of Investigator's Choice — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) positivity
Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
Required: PIK3CA mutation
Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
Disease stage
Metastatic disease required
metastatic or locally advanced disease not amenable to curative resection
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PI3K inhibitor
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
Cannot have received: AKT inhibitor
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
Cannot have received: mTOR inhibitor
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
Cannot have received: systemic non-hormonal anti-cancer therapy
Exception: prior to initiation of induction therapy
Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
Cannot have received: HER2-targeted therapy
Exception: disease progression within 6 months of receiving any HER2-targeted therapy
Disease progression within 6 months of receiving any HER2-targeted therapy
Lab requirements
Blood counts
Adequate hematologic function prior to initiation of study treatment
Kidney function
Adequate organ function prior to initiation of study treatment
Liver function
Adequate organ function prior to initiation of study treatment; exclusion of clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Cardiac function
LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
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 of clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner Health MD Anderson AZ · Gilbert, Arizona
- Disney Family Cancer Center · Burbank, California
- City of Hope · Corona, California
- City of Hope Comprehensive Cancer Center · Duarte, California
- City of Hope at Irvine Lennar · Irvine, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify