TNBC - Triple-Negative Breast CancerPhase 2NCT07101614
A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).
A Phase 2 study testing JS004 in combination with toripalimab and chemotherapy, Toripalimab and chemotherapy and Chemotherapy in people with TNBC - Triple-Negative Breast Cancer, run by Shengjing Hospital.
Trial summary
The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- JS004 in combination with toripalimab and chemotherapy, Toripalimab and chemotherapy and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Nov 2028
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
- Age ≥ 18 years.
- ECOG score ≤ 1.
- Newly diagnosed, non-metastatic breast cancer of stage II-III, confirmed by histopathology or cytopathology (T1c-2 cN1-2 (≥2cm) or T3-4 cN0-2).
- Pathologically confirmed hormone receptor-negative (ER and PR negative) and HER2-negative advanced breast cancer. In cases of multiple pathological results, the definition of triple-negative breast cancer is based on the final molecular subtype result from the last biopsy pathology. (ER negativity: immunohistochemical staining in <1% of tumor cells; PR negativity: immunohistochemical staining in <1% of tumor cells; HER2 negativity: immunohistochemical score of 0, 1+, or FISH/CISH negative).
- Have at least one measurable lesion according to the RECIST v1.1 criteria.
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- Functional levels of vital organs must meet the following requirements (without any corrective treatment with blood components or cytokine growth factors within 14 days before the first dose):
- Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 90 g/L.
- Liver and kidney function: Albumin level ≥ 3.0 g/dL, total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN, urea nitrogen and serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula).
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%.
- QTcF ≤ 470 msec.
- Within 7 days before the first dose, women of reproductive potential must have a negative serum pregnancy test and agree to use effective contraceptive measures during the study drug administration and for 6 months after the last dose. For this protocol, women of reproductive potential are defined as sexually mature women who: 1) have not undergone hysterectomy or bilateral oophorectomy, and 2) have not experienced spontaneous menstruation cessation for a continuous period of 24 months (amenorrhea following cancer treatment does not exclude fertility) (i.e., menstruation has occurred at any time within the previous 24 consecutive months). For male patients with female partners of reproductive potential, they must agree to use effective contraceptive measures during the study drug administration and for 6 months after the last dose.
- Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with visits and study-related procedures.
Who cannot join
- Prior exposure to drugs targeting the same therapeutic target as the study treatment drug planned for administration.
- Radiotherapy, chemotherapy, surgery, or other targeted immunotherapy for triple-negative breast cancer before enrollment.
- Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom control).
- Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer.
- History of clinically significant or uncontrolled cardiac disease within 6 months before the first dose, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmias.
- Presence of severe concomitant diseases that, in the investigator's judgment, pose a significant risk to the patient's safety or ability to complete the study (including but not limited to severe hypertension not controlled by medication, severe diabetes, active infections, etc.).
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- Malignancy within 5 years before the first dose (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ).
- Active autoimmune diseases requiring systemic treatment within 2 years before the first dose, except for vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy.
- Receipt of live or attenuated vaccines within 4 weeks before the first dose of the study drug.
- Known or suspected interstitial pneumonia. Presence of other moderate to severe respiratory diseases within 3 months before the first dose that may interfere with the detection or management of drug-related lung toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung diseases, etc.; as well as any autoimmune, connective tissue, or inflammatory diseases affecting the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc., or prior total lung resection surgery.
- Known history of human immunodeficiency virus (HIV) infection.
- Known history of hepatitis B or active hepatitis C virus infection.
- Prior allergy to any component or excipient of the study drug planned for administration.
- Other conditions deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Randomized, Multi-center, Multi-cohort Clinical Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).
The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- JS004 in combination with toripalimab and chemotherapy, Toripalimab and chemotherapy, Chemotherapy
- 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.
JS004 in combination with toripalimab and chemotherapyDrug
BTLA inhibitor (JS004):200mg, IV infusion , d1, Q3W;(1-24 week)
Toripalimab:240mg, IV infusion , d1, Q3W;(1-24 week)
Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week)
Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week)
Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week)
Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)
Toripalimab and chemotherapyDrug
Toripalimab:240mg, IV infusion , d1, Q3W;(1-24 week)
Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week)
Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week)
Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week)
Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)
ChemotherapyDrug
Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week)
Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week)
Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week)
Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)
| Study group | Role | What they receive |
|---|---|---|
| JS004+Toripalimab+chemotherapy | Experimental | Not described Receives: Drug: JS004 in combination with toripalimab and chemotherapy |
| Toripalimab+chemotherapy | Experimental | Not described Receives: Drug: Toripalimab and chemotherapy |
| chemotherapy | Other | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR) rate
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
Measured: Up to 30 months
Secondary outcomes (5)
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Measured: Up to 30 months
Breast pathologic complete response (bpCR)
The bpCR is defined as the histological evidence of no malignancy in the primary lesion of breast cancer, or only carcinoma in situ (i.e., ypT0/Tis, in accordance with current AJCC staging system).
Measured: Up to 30 months
Residual Cancer Burden (RCB) 0-1
Rate of RCB 0-1 at time of surgery
Measured: Up to 30 months
Event-free Survival (EFS)
Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression
Measured: Up to 30 months
Incidence of adverse event
Including type, incidence, severity, time and so on of adverse events
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101614
- Sponsor's protocol ID
- TNBC-IIT-JS004-N01
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center, Multi-cohort Clinical Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).
- ClinicalTrials.gov ID
- NCT07101614
- Acronym / sponsor ID
- TNBC-IIT-JS004-N01
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Aug 2025 (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 objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JS004+Toripalimab+chemotherapy | Experimental | Drug: JS004 in combination with toripalimab and chemotherapy |
| Toripalimab+chemotherapy | Experimental | Drug: Toripalimab and chemotherapy |
| chemotherapy | Other | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
- Age ≥ 18 years.
- ECOG score ≤ 1.
- Newly diagnosed, non-metastatic breast cancer of stage II-III, confirmed by histopathology or cytopathology (T1c-2 cN1-2 (≥2cm) or T3-4 cN0-2).
- Pathologically confirmed hormone receptor-negative (ER and PR negative) and HER2-negative advanced breast cancer. In cases of multiple pathological results, the definition of triple-negative breast cancer is based on the final molecular subtype result from the last biopsy pathology. (ER negativity: immunohistochemical staining in <1% of tumor cells; PR negativity: immunohistochemical staining in <1% of tumor cells; HER2 negativity: immunohistochemical score of 0, 1+, or FISH/CISH negative).
Key exclusion criteria (14 listed)
- Prior exposure to drugs targeting the same therapeutic target as the study treatment drug planned for administration.
- Radiotherapy, chemotherapy, surgery, or other targeted immunotherapy for triple-negative breast cancer before enrollment.
- Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom control).
- Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer.
- History of clinically significant or uncontrolled cardiac disease within 6 months before the first dose, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmias.
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 |
|---|---|---|
| JS004 in combination with toripalimab and chemotherapyBTLA inhibitor (JS004):200mg, IV infusion , d1, Q3W;(1-24 week) Toripalimab:240mg, IV infusion , d1, Q3W;(1-24 week) Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week) | Drug | JS004+Toripalimab+chemotherapy |
| Toripalimab and chemotherapyToripalimab:240mg, IV infusion , d1, Q3W;(1-24 week) Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week) | Drug | Toripalimab+chemotherapy |
| ChemotherapyCarboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week) | Drug | chemotherapy |
Primary outcome
Pathologic complete response (pCR) rate
Time frame: Up to 30 months
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 30 months
Breast pathologic complete response (bpCR)
Time frame: Up to 30 months
Residual Cancer Burden (RCB) 0-1
Time frame: Up to 30 months
Event-free Survival (EFS)
Time frame: Up to 30 months
Incidence of adverse event
Time frame: Up to 30 months
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 3 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS004 in combination with toripalimab and chemotherapy, Toripalimab and chemotherapy and Chemotherapy in people with TNBC - Triple-Negative Breast Cancer, run by Shengjing Hospital.
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 14 inclusion and 14 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Nan Niu (86-18940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) rate (time frame: Up to 30 months). 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 3 Aug 2025.