Targeted therapy for advanced breast cancer with a PIK3CA change
Part of Cancer, Skin clinical trials.
This trial tests a combination of three targeted therapies (inavolisib, ribociclib, and fulvestrant) in people with a specific type of advanced breast cancer that has a PIK3CA genetic change. The goal is to see if this new combination can shrink tumors or slow cancer growth, potentially offering a new option before other treatments are needed.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are a woman aged 18 or older and are postmenopausal (or willing to take a medication to suppress ovarian function).
- Your breast cancer is HR-positive and HER2-negative, and it has advanced or spread to other parts of the body and cannot be removed by surgery.
- Your tumor must have a specific genetic change called a PIK3CA mutation, which will be tested from a blood sample or tumor tissue.
- Your cancer must have grown while you were on or within 12 months after finishing hormone therapy for early-stage disease. If you took a CDK4/6 inhibitor, the growth must be more than 12 months after stopping it.
- You have not had any prior systemic treatment for advanced/metastatic breast cancer, and you have not taken certain targeted drugs (like PI3K, AKT, or mTOR inhibitors).
- You must have at least one measurable tumor lesion (not just in the bones), and you must be generally healthy (ECOG performance status 0 or 1).
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This trial tests whether a new targeted pill (inavolisib) plus hormone therapy (fulvestrant) can slow or stop breast cancer growth in people whose cancer has a specific genetic change called a PIK3CA mutation. It is for patients whose disease worsened after previous hormone-and-CDK-inhibitor treatment.
This study tests a new drug called inavolisib for people with early-stage breast cancer that has a specific genetic change (PIK3CA mutation). The goal is to see if adding this drug to standard hormone therapy is safe and effective before surgery.
This trial tests whether a new drug combo (inavolisib plus fulvestrant) works better than an existing one (alpelisib plus fulvestrant) for people with a specific type of advanced breast cancer that has a PIK3CA mutation. It aims to find a treatment that may help control the cancer longer.
This trial tests a combination of three drugs (inavolisib, ribociclib, and fulvestrant) compared to a placebo plus two of the drugs (ribociclib and fulvestrant) for people with advanced hormone receptor-positive breast cancer who have not had prior treatment for advanced disease. The goal is to see if adding inavolisib improves outcomes.
This trial tests a new targeted therapy, inavolisib, combined with standard hormone therapy and a CDK4/6 inhibitor for people with a specific genetic mutation (PIK3CA) in their hormone receptor-positive, HER2-negative advanced breast cancer that has not been treated before. It compares this combination to a placebo plus the same standard treatments.
This study looks at how well a drug called inavolisib works when combined with hormone therapy for people with a certain type of advanced breast cancer that has a specific gene change (PIK3CA). It aims to see if this treatment helps control the cancer in real-world settings.
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