Locally Advanced or Metastatic Triple-negative Breast Cancer
Conditions
Keywords
triple-negative breast cancer
Brief 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
Interventions
DRUG9MW2821
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
DRUGChemotherapy
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.
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to approximately 2 years | Time from the date of randomization until the date of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate per investigator | Up to approximately 2 years | The percentage of subjects who experience a best response of either CR or PR. |
| Duration of Response per investigator | Up to approximately 2 years | Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. |
| Time to response per investigator | Up to approximately 2 years | Time from the date of randomization to the date of CR or PR. |
| Disease Control Rate per investigator | Up to approximately 2 years | The percentage of subjects who experience a best response of CR, PR or stable disease (SD). |
| Progression Free Survival per investigator | Up to approximately 2 years | Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause. |
| Incidence of adverse events | Up to approximately 2 years | — |
| Incidence of Anti-Drug Antibody (ADA) | Up to approximately 2 years | — |
Countries
China
Contacts
CONTACTJiong Wu
CONTACTJian Zhang
Outcome results
None listed