Sirolimus plus palbociclib and fulvestrant for advanced breast cancer
Treatments studied
Part of Cancer clinical trials.
This trial tests a new form of the drug sirolimus (bound to albumin) combined with two other drugs (palbociclib and fulvestrant) for advanced breast cancer. It aims to see if this combination is safe and effective for people with the HR-positive, HER2-negative subtype.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 or older.
- You have a type of breast cancer called HR-positive and HER2-negative (these are markers on the cancer cells).
- If you are in the dose-escalation part, any previous treatments are allowed. If in the dose-expansion part, you must have had hormone therapy and it stopped working; you may have had only one line of chemo for advanced disease; and you have not had CDK4/6 inhibitor treatment for advanced disease.
- You have at least one tumor that can be measured on scans (except patients with only bone metastases may join the dose-escalation part).
- You are generally active (ECOG score 0-1) and expected to live more than 6 months.
- Your organs (heart, liver, kidneys, blood counts) are working well enough per the protocol.
- You are not allowed to participate if you have certain other conditions (e.g., severe lung disease, uncontrolled fluid buildup, bleeding disorders, or prior treatment with fulvestrant or PI3K/AKT/mTOR inhibitors).
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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