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NCT05431504Possibly a fitNot yet recruiting

Dalpiciclib plus hormone therapy for advanced breast cancer flare-ups

Advanced Breast Cancer

Part of Cancer clinical trials.

This Phase 2 trial tests dalpiciclib (a cancer medicine) added to standard hormone therapy for women with advanced, hormone-receptor–positive and HER2-negative breast cancer that has serious “visceral crisis” symptoms (like fluid buildup, liver issues, or other urgent organ involvement). It aims to see whether this combination can shrink cancer and improve safety compared with hormone therapy alone.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
53 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have advanced breast cancer that is hormone-receptor positive (ER and/or PR) and HER2-negative, confirmed by lab testing.
  • Your cancer is not considered curable by surgery or radiation aimed at cure.
  • You have “visceral crisis” or symptomatic metastasis, or you can’t safely tolerate chemotherapy (as judged by the study doctor).
  • You must meet blood-count targets (enough white blood cells, platelets, and hemoglobin) from recent lab tests.
  • If you are not fully postmenopausal or surgically sterile, you must have a negative pregnancy test and use reliable birth control during the study and for 1 year after.
  • You have not had certain prior treatments (including prior CDK4/6 inhibitors) and you do not have specific major infections or severe recent heart/stroke problems.

View the official record on ClinicalTrials.gov

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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