A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 9MW2821, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Triple-negative Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Drug 9MW2821
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol - Drug Chemotherapy
Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine.
Primary outcome measures
- Overall Survival [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
- Objective Response Rate per investigator [Time frame: Up to approximately 2 years]
- Duration of Response per investigator [Time frame: Up to approximately 2 years]
- Time to response per investigator [Time frame: Up to approximately 2 years]
- Disease Control Rate per investigator [Time frame: Up to approximately 2 years]
- Progression Free Survival per investigator [Time frame: Up to approximately 2 years]
- Incidence of adverse events [Time frame: Up to approximately 2 years]
- Incidence of Anti-Drug Antibody (ADA) [Time frame: Up to approximately 2 years]
Eligibility criteria
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 investigational product; History of drug abuse or mental illness.
- Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases .
- Active autoimmune disease.
- History of another malignancy .
- Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.
- Not suitable to receive study treatment for other conditions as per investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07556848 · 9MW2821-CP305