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A Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
EU CTIS ID: 2023-505812-39-00
What this study is testing
To evaluate the efficacy of inavolisib plus palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant on the basis of progression-free survival
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed diagnosis of HR+/HER2-negative breast cancer
- Metastatic or Locally Advanced disease not amenable to curative therapy
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
You likely can't join if
- Metaplastic breast cancer
- Any history of leptomeningeal disease or carcinomatous meningitis
- Any prior systemic therapy for metastatic breast cancer
- Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of patients that have received fulvestrant or any selective estrogen receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Australia
- Georgia
- Russian Federation
- Hong Kong
- Ukraine
- United Kingdom
- Brazil
- Canada
- Singapore
- Malaysia
- Thailand
- Turkey
- Argentina
- New Zealand
- United States
- Korea, Republic of
- China
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Australia; Georgia; Russian Federation; Hong Kong; Ukraine and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.