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NCT06486883Possibly a fitRecruiting

T-DXd vs CDK4/6i plus hormone therapy for advanced HR-positive, HER2-low breast cancer

Advanced Breast CancerAdvanced Breast CarcinomaHormone Receptor Positive Breast Carcinoma

Treatments studied

Part of Cancer clinical trials.

This trial compares two treatments for advanced breast cancer that is HR-positive, HER2-low or ultralow, and a non-luminal subtype. It tests if a targeted antibody-drug conjugate (T-DXd) works better than the usual first-line therapy combining a CDK4/6 inhibitor with hormone therapy. This study is for people who have not had any treatment for advanced disease.

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

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

Who can take part

  • You have a type of breast cancer called HR-positive, HER2-low or HER2-ultralow, and a non-luminal subtype (determined by a special test).
  • You have never received any chemotherapy, hormone therapy, or targeted therapy for breast cancer that has spread to other parts of the body.
  • Your cancer either came back while you were on hormone therapy or within 1 year of finishing it, or if you were diagnosed with metastatic cancer from the start, you have certain features like a low estrogen receptor level, high tumor grade, high Ki67, liver metastases, or a non-luminal subtype.
  • You are in generally good health (able to do daily activities) and your kidney, liver, and blood cell counts are within acceptable ranges.
  • You have measurable tumors (not just in the bones) that can be seen on CT or MRI scans.

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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