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

Official 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

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 75 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 356 participants

Study Arms

• Experimental: 9MW2821 (EXPERIMENTAL)
  Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol
• Active Comparator: Investigator's Choice of Chemotherapy (ACTIVE_COMPARATOR)
  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.

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 Outcomes

• Overall Survival (Up to approximately 2 years)

Secondary Outcomes

• Objective Response Rate per investigator (Up to approximately 2 years)
• Duration of Response per investigator (Up to approximately 2 years)
• Time to response per investigator (Up to approximately 2 years)
• Disease Control Rate per investigator (Up to approximately 2 years)
• Progression Free Survival per investigator (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.

Trial Locations

• Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China

Contact Information

• Jiong Wu — CONTACT
  Phone: 021-64175590
  Email: wujiong1122@vip.sina.com
• Jian Zhang — CONTACT
  Phone: 021-64175590
  Email: syner2000@163.com

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