Paclitaxel (albumin-bound) bioequivalence study in breast cancer
Part of Cancer, Skin clinical trials.
This study tests whether a new version of paclitaxel (albumin-bound) works the same as the approved version in people with breast cancer. It's for patients whose cancer has spread or returned after other treatments, or those for whom this drug is recommended by treatment guidelines.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must have breast cancer confirmed by biopsy or lab testing.
- Your cancer must be metastatic (spread) and not responding to chemotherapy, or returned within 6 months of finishing adjuvant chemo (you would have taken an anthracycline drug before).
- You are between 18 and 75 years old, with a body mass index (BMI) of 17 or higher.
- You must be able to care for yourself (ECOG score 0-2) and have a life expectancy of at least 3 months.
- You must not be pregnant or planning pregnancy, and must use effective contraception during the study and for 6 months after the last dose.
- You must have adequate blood cell counts and liver/kidney function as shown by lab tests.
- You cannot have had chemotherapy, radiation, immunotherapy, or hormone therapy within 4 weeks before starting the study drug.
- You cannot have serious heart problems, uncontrolled high blood pressure, or active infections like hepatitis B, hepatitis C, or HIV.
- You cannot be taking certain medications that interfere with the drug, such as some antifungals, antibiotics, or seizure medicines.
- You must not have a history of heavy alcohol use, drug abuse, or smoking more than 5 cigarettes a day in the last 3 months.
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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