Prifetrastat plus fulvestrant for advanced breast cancer
Part of Cancer, Skin clinical trials.
This trial tests a new drug, prifetrastat, combined with an existing hormone therapy (fulvestrant) for people with hormone receptor-positive, HER2-negative breast cancer that has spread to other organs. The goal is to see if the combination can control the cancer better than fulvestrant alone.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be 18 or older.
- You must have advanced breast cancer that is hormone receptor positive and HER2 negative.
- Your cancer must have grown after at least one prior treatment with a CDK4/6 inhibitor (like palbociclib, ribociclib, or abemaciclib) and at least one prior endocrine therapy.
- You cannot have had more than 3 prior lines of systemic therapy for advanced disease, including up to 2 lines of chemotherapy for visceral disease.
- You need to have a tumor sample (biopsy) available and be willing to have a new biopsy of a metastatic site that is not in bone and has not been previously irradiated.
- You must have at least one measurable lesion (tumor) that has not been irradiated.
- You must have an ECOG performance status of 0 or 1 (meaning you are fully active or restricted only in physically strenuous activity).
- Your bone marrow, kidney, liver, and blood clotting function must be within acceptable limits as per trial standards.
- If you are premenopausal, you must be willing to undergo medically induced menopause with an LHRH agonist (like goserelin).
- You cannot have active brain metastases that require steroids, or rapidly progressing visceral disease that puts you at immediate risk.
- You cannot have other active cancers within the past 3 years (except certain skin cancers or carcinoma in situ).
- You cannot have certain heart conditions, such as a recent heart attack, uncontrolled arrhythmias, or prolonged QT interval.
- You must not be taking certain medications that interact with the study drug (strong or moderate CYP3A4/5 inhibitors or inducers, and CYP2C9 inhibitors or inducers).
- You must be willing to use effective contraception during the study and for a period after.
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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