A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 9MW2821
  • Chemotherapy

Treatment groups

356 Participants
are divided into 2 treatment groups