A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced o… (NCT07556848) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer
China356 participantsStarted 2026-05
Plain-language summary
The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
* Male or female subjects aged 18 to 75 years (including 18 and 75 years).
* ECOG 0-1.
* Histopathological diagnosed triple-negative breast cancer.
* Patient has previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.
* Suitable for one of active comparator chemotherapy assessed by investigator.
* An archival tumor tissue sample or a fresh tissue sample should be provided.
* Life expectancy of ≥ 12 weeks.
* Subjects must have measurable disease according to RECIST (version 1.1).
* Adequate organ functions.
* Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
Exclusion Criteria:
* Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.
* Preexisting peripheral neuropathy Grade ≥ 2.
* Hemoglobin A1C (HbA1c) ≥ 8%.
* Has ocular conditions or symptoms that may increase the risk of the study.
* History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases and/or meningeal metastasis.
* Previous medication does not meet the requirements.
* Known sensitivity to any of the ingredients of the investigat…