Triple Negative Breast CancerPhase 3NCT07533123
A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
A Phase 3 study testing JSKN016 Injection, Eribulin Mcsilate Injection and Vinorelbine Tartrate Injection in people with Triple Negative Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee [BIRC] based on Response Evaluation Criteria in Solid Tumors [RECIST v1.1]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- JSKN016 Injection, Eribulin Mcsilate Injection and Vinorelbine Tartrate Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 17 Mar 2030
- 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
- Voluntarily sign the Informed Consent Form (ICF).
- Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically and/or cytologically confirmed diagnosis of Triple-Negative Breast Cancer (TNBC) based on pathology reports from the most recent biopsy or other pathological specimens.
- Failure of at least 2 prior lines of systemic chemotherapy.
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- At least one measurable extracranial lesion per Response Evaluation Criteria in Solid -Tumors (RECIST) v1.1.
- Agree to provide a tumor tissue specimen.
- Adequate organ and bone marrow function.
- Recovery from prior treatment-related toxicities to ≤ Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or as specified in the protocol for eligibility.
- Assessed by the investigator as suitable to receive one of the following: eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan.
- Female participants of childbearing potential must have a negative serum/urine pregnancy test within 7 days prior to randomization and agree to contraception during the trial.
Who cannot join
- Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs.
- Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ.
- Presence of cerebrovascular or cardiovascular diseases or risk factors.
- Inadequate washout from prior therapies prior to randomization.
- Presence of active central nervous system (CNS) metastases without prior local treatment; presence of metastases or compression of the brainstem, meninges, or spinal cord; or history of carcinomatous meningitis.
- Presence of severe or uncontrolled concomitant diseases that may affect safety or compliance.
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- Tumor invasion of adjacent vital organs or blood vessels (such as the heart, esophagus, superior vena cava, etc.) or risk of developing an esophagotracheal fistula or esophagopleural fistula.
- Active hepatitis B; active hepatitis C.
- Positive test for human immunodeficiency virus (HIV) or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; known active tuberculosis infection.
- History of allogeneic bone marrow or organ transplantation.
- History of significant ophthalmic diseases.
- History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment.
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, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510289
Herui Yao, MD, 13500018020, yaoherui@163.com
Jian Zhang, MD, 021-64175590, syner2000@163.com
About this study
Official title: A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy
Primary Endpoint of this Study:
To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee [BIRC] based on Response Evaluation Criteria in Solid Tumors [RECIST v1.1]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).
To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- JSKN016 Injection, Eribulin Mcsilate Injection, Vinorelbine Tartrate Injection, Capecitabine Tablets, Gemcitabine Hydrochloride for Injection
- 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.
JSKN016 InjectionDrug
Injection; 100 mg (4.0 mL)/vial. Dosage: 6 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle
Eribulin Mcsilate InjectionDrug
Injection; 2 mL:1 mg (0.5 mg/mL). Dosage: 1.4 mg/m² administered via intravenous bolus on Day 1 and Day 8 of each 21-day cycle
Vinorelbine Tartrate InjectionDrug
Injection; 1 mL:10 mg (10 mg/mL). Dosage: 25 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Capecitabine TabletsDrug
Tablet; 0.15 g and 0.5 g. Dosage: 1000-1250 mg/m² orally once daily on Days 1-14 of each 21-day cycle (14 days on/7 days off)
Gemcitabine Hydrochloride for InjectionDrug
Injection; 0.2 g. Dosage: 1000 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Sacituzumab Govitecan for InjectionDrug
Injection; 180 mg/vial. Dosage: 10 mg/kg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| JSKN016 | Experimental | Not described Receives: Drug: JSKN016 Injection |
| Treatment of Physician's Choice | Active comparator | Not described Receives: Drug: Eribulin Mcsilate Injection; Drug: Vinorelbine Tartrate Injection; Drug: Capecitabine Tablets; Drug: Gemcitabine Hydrochloride for Injection; Drug: Sacituzumab Govitecan for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression-Free Survival)
PFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 as assessed by BIRC, or death from any cause, whichever occurs first.
Measured: From randomization to date of first documented progression or date of death from any cause. Up to approximately 3 years after the first enrollment.
OS (Overall Survival)
OS is defined as the time from randomization to death from any cause.
Measured: From randomization to date of death from any cause.Up to approximately 3 years after the first enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start17 Mar 2026 (estimated)
- Primary completion17 Mar 2029 (estimated)
- Study completion17 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533123
- Sponsor's protocol ID
- JSKN016-301
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 16 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT07533123
- Acronym / sponsor ID
- JSKN016-301
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (estimated)
- Primary completion
- 17 Mar 2029 (estimated)
- Study completion
- 17 Mar 2030 (estimated)
- First posted
- 16 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.
Primary Endpoint of this Study:
To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee [BIRC] based on Response Evaluation Criteria in Solid Tumors [RECIST v1.1]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).
To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JSKN016 | Experimental | Drug: JSKN016 Injection |
| Treatment of Physician's Choice | Active comparator | Drug: Eribulin Mcsilate Injection, Drug: Vinorelbine Tartrate Injection, Drug: Capecitabine Tablets, Drug: Gemcitabine Hydrochloride for Injection, Drug: Sacituzumab Govitecan for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign the Informed Consent Form (ICF).
- Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically and/or cytologically confirmed diagnosis of Triple-Negative Breast Cancer (TNBC) based on pathology reports from the most recent biopsy or other pathological specimens.
Key exclusion criteria (12 listed)
- Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs.
- Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ.
- Presence of cerebrovascular or cardiovascular diseases or risk factors.
- Inadequate washout from prior therapies prior to randomization.
- Presence of active central nervous system (CNS) metastases without prior local treatment; presence of metastases or compression of the brainstem, meninges, or spinal cord; or history of carcinomatous meningitis.
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 |
|---|---|---|
| JSKN016 InjectionInjection; 100 mg (4.0 mL)/vial. Dosage: 6 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle | Drug | JSKN016 |
| Eribulin Mcsilate InjectionInjection; 2 mL:1 mg (0.5 mg/mL). Dosage: 1.4 mg/m² administered via intravenous bolus on Day 1 and Day 8 of each 21-day cycle | Drug | Treatment of Physician's Choice |
| Vinorelbine Tartrate InjectionInjection; 1 mL:10 mg (10 mg/mL). Dosage: 25 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle | Drug | Treatment of Physician's Choice |
| Capecitabine TabletsTablet; 0.15 g and 0.5 g. Dosage: 1000-1250 mg/m² orally once daily on Days 1-14 of each 21-day cycle (14 days on/7 days off) | Drug | Treatment of Physician's Choice |
| Gemcitabine Hydrochloride for InjectionInjection; 0.2 g. Dosage: 1000 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle | Drug | Treatment of Physician's Choice |
| Sacituzumab Govitecan for InjectionInjection; 180 mg/vial. Dosage: 10 mg/kg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle | Drug | Treatment of Physician's Choice |
Primary outcome
PFS (Progression-Free Survival)
Time frame: From randomization to date of first documented progression or date of death from any cause. Up to approximately 3 years after the first enrollment.
PFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 as assessed by BIRC, or death from any cause, whichever occurs first.
OS (Overall Survival)
Time frame: From randomization to date of death from any cause.Up to approximately 3 years after the first enrollment.
OS is defined as the time from randomization to death from any cause.
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 16 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 JSKN016 Injection, Eribulin Mcsilate Injection and Vinorelbine Tartrate Injection in people with Triple Negative Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals 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 12 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: looking for participants now, as of the sponsor's last update on 16 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 Yuan Huang (0512-62850800, yuanhuang@alphamabonc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (Progression-Free Survival) (time frame: From randomization to date of first documented progression or date of death from any cause. Up to approximately 3 years after the first enrollment.). The study lists 2 primary outcomes in all. 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 16 Apr 2026.