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NCT07487519Possibly a fitNot yet recruiting

Experimental drug for advanced triple-negative breast cancer

Breast Cancer (Triple Negative Breast Cancer (TNBC))

Part of Cancer, Skin clinical trials.

This trial tests an experimental drug called HLX43, given alone or with other immune-boosting drugs, for people with advanced triple-negative breast cancer (a type of breast cancer that does not have the common hormone receptors). The goal is to see if this drug can shrink tumors or slow cancer growth.

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

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

Who can take part

  • You must be 18 or older.
  • Your tumor must be confirmed as triple-negative breast cancer (meaning it is negative for estrogen, progesterone, and HER2 receptors).
  • Your cancer must be locally advanced, recurrent, or metastatic — meaning it has spread or come back and cannot be removed with surgery.
  • If you have not yet received any systemic treatment for advanced disease, you can join Phase II. If you have had one or more prior lines of standard treatment for recurrent/metastatic disease, you can join Phase I.
  • You must have at least one measurable tumor that can be seen on a scan, and it must not be in an area previously treated with radiation unless it has grown since.
  • You must be able to provide a tumor tissue sample (from a previous biopsy or surgery) for testing.
  • You must have good performance status (ECOG 0-1), meaning you are up and about with little or no help.
  • You must have adequate organ function (bone marrow, liver, kidneys).
  • You cannot have had certain prior treatments like irinotecan, topotecan, or some ADCs that target Trop-2.
  • You cannot have active brain metastases, autoimmune disease, uncontrolled infections, or be pregnant or breastfeeding.

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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