Clin2
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, Hormones & metabolism 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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