Locally Advanced or Metastatic Triple-negative Breast CancerPhase 3NCT07556848
A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer
A Phase 3 study testing 9MW2821 and Chemotherapy in people with Locally Advanced or Metastatic Triple-negative Breast Cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Triple-negative Breast Cancer
- What is being tested?
- 9MW2821 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jiong Wu, 021-64175590, wujiong1122@vip.sina.com
Jian Zhang, 021-64175590, syner2000@163.com
About this study
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
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
- Being tested
- 9MW2821, Chemotherapy
- Keywords
- triple-negative breast cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW2821Drug
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 9MW2821 | Experimental | Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol Receives: Drug: 9MW2821 |
| 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. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from the date of randomization until the date of death from any cause
Measured: Up to approximately 2 years
Secondary outcomes (7)
Objective Response Rate per investigator
The percentage of subjects who experience a best response of either CR or PR.
Measured: Up to approximately 2 years
Duration of Response per investigator
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.
Measured: Up to approximately 2 years
Time to response per investigator
Time from the date of randomization to the date of CR or PR.
Measured: Up to approximately 2 years
Disease Control Rate per investigator
The percentage of subjects who experience a best response of CR, PR or stable disease (SD).
Measured: Up to approximately 2 years
Progression Free Survival per investigator
Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.
Measured: Up to approximately 2 years
Incidence of adverse events
Measured: Up to approximately 2 years
Incidence of Anti-Drug Antibody (ADA)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556848
- Sponsor's protocol ID
- 9MW2821-CP305
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07556848
- Acronym / sponsor ID
- 9MW2821-CP305
- Keywords
- triple-negative breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 9MW2821 | Experimental | Drug: 9MW2821Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol |
| Active Comparator: Investigator's Choice of Chemotherapy | Active comparator | Drug: ChemotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9MW2821Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol | Drug | Experimental: 9MW2821 |
| ChemotherapyParticipants 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. | Drug | Active Comparator: Investigator's Choice of Chemotherapy |
Primary outcome
Overall Survival
Time frame: Up to approximately 2 years
Time from the date of randomization until the date of death from any cause
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 9MW2821 and Chemotherapy in people with Locally Advanced or Metastatic Triple-negative Breast Cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiong Wu (021-64175590, wujiong1122@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.