Trial comparing treatments for Metastatic Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT05894239
What this study is testing
What is Inavolisib?
Inavolisib is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether adding inavolisib to standard Phesgo therapy improves how well the cancer is controlled and remains safe as a maintenance treatment.
- Who it's for
- Adults with HER2‑positive, PIK3CA‑mutated locally advanced or metastatic breast cancer who have not received prior treatment for this stage.
- What's involved
- Participants will take a daily pill of inavolisib (or a matching placebo) and receive regular subcutaneous injections of Phesgo, along with scheduled clinic visits for exams, blood tests, and imaging scans.
- Time commitment
- The trial continues until disease progression, with regular clinic visits and tests over several months.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \>= 6 months
You likely can't join 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...
- Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction...
- 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
See the full eligibility 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
- 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...
- Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Burbank, California, United States
- Corona, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Hyattsville, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Charlotte, North Carolina, United States
- El Paso, Texas, United States
- Fort Worth, Texas, United States
- The Woodlands, Texas, United States
- Kennewick, Washington, United States
- Seattle, Washington, United States
- Fortaleza, Ceará, Brazil
- Salvador, Estado de Bahia, Brazil
- Goiânia, Goiás, Brazil
- Londrina, Paraná, Brazil
+ 53 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Burbank, California, United States; Corona, California, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States and 67 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.