NCT07556848Not yet recruitingPhase 3
A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer
A Randomized, Open-label, Phase 3 Study to Evaluate 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
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 356 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- May 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07556848
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 356
- From May 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous medication does not meet the requirements.
- Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
Other illness
- 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.
- Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases .
- Active autoimmune disease.
- History of another malignancy .
- Not suitable to receive study treatment for other conditions as per investigator.
Lab values
- Hemoglobin A1C (HbA1c) ≥ 8%.
Other
- Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.
- Preexisting peripheral neuropathy Grade ≥ 2.
- Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.