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
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (20)
AZ
- Banner Health MD Anderson AZ · Gilbert, AZ 85234More trials in Gilbert
CA
- Disney Family Cancer Center · Burbank, CA 91505More trials in Burbank
- City of Hope · Corona, CA 92882More trials in Corona
- City of Hope Comprehensive Cancer Center · Duarte, CA 91010More trials in Duarte
- City of Hope at Irvine Lennar · Irvine, CA 92618More trials in Irvine
- Ellison Medical Institute · Los Angeles, CA 90064More trials in Los Angeles
DC
- Georgetown Uni Hospital · Washington D.C., DC 20007More trials in Washington D.C.
MA
- Dana Farber Cancer Institute · Boston, MA 02215More trials in Boston
MD
- Medstar Research Institute · Hyattsville, MD 20783More trials in Hyattsville
MI
- Henry Ford Hospital · Detroit, MI 48202More trials in Detroit
NC
- Atrium Health · Charlotte, NC 28209More trials in Charlotte
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601More trials in Hackensack
NV
- Renown Regional Medical Center · Reno, NV 89502More trials in Reno
OK
- Hightower Clinical · Oklahoma City, OK 73102More trials in Oklahoma City
TX
- Renovatio Clinical - El Paso · El Paso, TX 79915More trials in El Paso
- JPS Health Network · Fort Worth, TX 76104More trials in Fort Worth
- Lumi Research · Kingwood, TX 77339More trials in Kingwood
- Renovatio Clinical · The Woodlands, TX 77380More trials in The Woodlands
WA
- Kadlec Clinic Hematology and Oncology · Kennewick, WA 99336-7774More trials in Kennewick
- Swedish Medical Center · Seattle, WA 98104-1360More trials in Seattle