TNBC - Triple-Negative Breast CancerPhase 3NCT05862064
A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer
A Phase 3 study testing epirubicin,cyclophosphamide,paclitaxel,Carrelizumab and epirubicin,cyclophosphamide,paclitaxel in people with TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- epirubicin,cyclophosphamide,paclitaxel,Carrelizumab and epirubicin,cyclophosphamide,paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jul 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the Informed Consent Form (ICF)
- The patient is judged by the investigator to have the ability to comply with the provisions of the protocol
- Women aged 18~70 at the time of signing the ICF
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0
- Histological results recorded as TNBC (negative HER2, ER and PgR status)
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- Adequate excision: Patients must have undergone breast-conserving or mastectomy/nipple-sparing mastectomy.
- Pathological tumor-lymph node metastasis staging (IUCC/Joint American Committee on Cancer [UICC/AJCC], 8th edition): Patients undergoing pathologic lymph node status assessment must undergo sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection. As mentioned above, patients with simultaneous bilateral invasive disease are eligible only if all bilateral invasive lesions are confirmed by histological examination by the central laboratory as triple-negative lesions and bilateral pathopathological-lymph node metastasis staging has been completed. The interval between final breast cancer surgery (or the last surgery for cure if additional resection of breast cancer is required) and randomization should not exceed 8 weeks (56 days).
- Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Lymphocyte count≥ 500 cells/μL; Platelet count≥ 100,000 cells/μL (no platelet transfusion within 2 weeks before day 1 of course 1; hemoglobin≥ 9.0 g/dL; AST, ALT, and alkaline phosphatase≤ 2.5 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; Patients with known Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted; For patients not receiving anticoagulant therapy: INR or aPTT ≤ 1.5 × ULN within 28 days prior to initiation of study therapy; For patients receiving anticoagulant therapy: a stable anticoagulant regimen within 28 days before the start of study therapy and a stable INR; creatinine clearance≥ 30 mL/min (calculated using the Cockcroft-Gault formula); Serum albumin ≥ 2.5 g/dL
- For women of childbearing age: agree to remain abstinent (avoid heterosexual intercourse) or take an annual failure rate for at least 5 months during treatment and at least 5 months after the last dose of SHR1210 (carrelizumab), or 6 months after the last dose of paclitaxel or doxorubicin, or 12 months after the last dose of cyclophosphamide, whichever occurs last < 1% of contraception. A woman who is postmenopausal but has not yet reached postmenopausal status (menopause lasts ≥for 12 consecutive months, for no reason other than menopause) and has not undergone sterilization (ovarian and/or hysterectomy) is considered fertile.
- Have the willingness and ability to follow scheduled visits, treatment protocols, laboratory tests and other research procedures
Who cannot join
- Have a history of invasive breast cancer
- T4 clinical tumors as specified in the UICC/AJCC Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer
- For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer RT, except for treatments planned under this study condition
- Previous treatment with anthracyclines or taxane for any malignant tumor
- History of DCIS and/or LCIS, treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or RT, followed by invasive cancer, patients treated with DCIS/LCIS only surgery and/or RT for contralateral DCIS may be enrolled in the study.
- Prior to randomization, cardiopulmonary dysfunction according to any of the following: history of NCI CTCAE v4.0 ≥3 symptomatic congestive heart failure or New York College of Cardiology (NYHA) standard classification≥ II, angina requiring antianginal drugs, severe arrhythmias not treated with appropriate medical therapy, severe conduction abnormalities, or clinically significant valvular disease, high-risk, uncontrolled arrhythmias (i.e., atrial tachycardia with > resting rate). 100/min, significant ventricular arrhythmia [ventricular tachycardia], or high-grade atrioventricular [AV] block [second-degree AV block type 2, or third-degree atrioventricular block]), significant symptoms associated with left ventricular dysfunction, arrhythmia, or myocardial ischemia (grade ≥2), myocardial infarction within 12 hours prior to randomization; with uncontrolled hypertension (systolic blood pressure> 180 mmHg and/or diastolic blood pressure > 100 mmHg; ECG findings show transmural infarction; Oxygen therapy is required
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- Prior malignancy within 5 years prior to randomization, with negligible risk of metastasis or death, except for malignancy that is expected to heal after treatment (i.e., appropriately treated carcinoma in situ or basal or squamous cell skin cancer).
- Have a history of severe allergic reactions, allergic reactions or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; Hypersensitivity to biopharmaceutical products produced by Chinese hamster ovary cells is known; Known allergic or hypersensitivity to any component of the SHR1210 (carrelizumab) preparation; known allergic or hypersensitivity to any component of paclitaxel (eg, polyoxyethylene 35 castor oil), cyclophosphamide, or doxorubicin/epirubicin preparations; Allergic or hypersensitivity reactions are known to filgrastine, pefistim, or GM-CSF preparations
- Have a history of active or previous autoimmune disease or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, except in patients with a history of autoimmune-related hypothyroidism, if receiving a stable dose of thyroid hormone replacement therapy, Participation in this study is available. People with type 1 diabetes who have controlled blood glucose on insulin dosing regimens may participate in this study. Patients with eczema, psoriasis, chronic lichen simplex, or vitiligo who present only with skin conditions (eg, patients with psoriatic arthritis should be excluded) are allowed to participate in this study, provided that all of the following criteria are met: the body surface area covered by the rash should be met <10%。 Disease is adequately controlled at baseline and only topical low-potency corticosteroid therapy is required. There has been no acute exacerbation of the underlying disease in the past 12 months and does not require treatment with psoralen + UV A irradiation, methotrexate, retinoids, biologics, oral calcineurin inhibitors, and highly active or oral glucocorticoids
- History of idiopathic pulmonary fibrosis, organic pneumonia (eg, bronchiolitis obliterans), drug-based. Patients with a history of radiation pneumonia (fibrosis) in the field where evidence of active pneumonia is detected on screening by chest computed tomography (CT) may participate in this study.
- Obstruction of urination
- Active tuberculosis
- Patients with serious infections (including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia) that occurred within 4 weeks prior to initiation of study treatment, who received therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment, and who received prophylactic antibiotic therapy (such as prophylaxis for urinary tract infection or prevention of chronic obstructive pulmonary disease) may be enrolled.
- Significant surgery within 4 weeks prior to study treatment initiation other than diagnosis, or expected to undergo major surgery during study treatment or within 5 months of last SHR1210 (carrelizumab) or famitinib (for patients randomized to SHR1210 (carrelizumab)).
- Have undergone allogeneic stem cell or solid organ transplantation
- Have received live attenuated vaccine within 4 weeks prior to initiation of study treatment, or expected to be required during the study or within 5 months of the last dose of SHR1210 (carrelizumab). Patients must agree not to receive influenza activated attenuated vaccines (e.g., FluMist®) for 28 days prior to randomization, during treatment, or 5 months after the last dose of SHR1210 (carrelizumab) (patients randomized to SHR1210 (carrelizumab)).
- Previous CD137 agonist or immune checkpoint blocking therapy, including anti-CD40, anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibody therapy
- Received systemic immunostimulant therapy (including but not limited to interferon, interleukin-2) within 4 weeks prior to initiation of study treatment or 5 times the half-life of the drug (whichever is longer)
- Systemic immunosuppressive drugs (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] α drugs) within 2 weeks prior to study initiation, or systemic immunosuppressive therapy is expected to be required during the study period, for patients who have received short-term, low-dose, systemic immunosuppressant therapy (e.g., a one-time dose of dexamethasone for nausea), in consultation with the medical monitor and approval by the medical monitor, Participation in this study is available. The use of inhaled glucocorticoids and mineralocorticoids (eg, fludrocortisone) is permitted.
- Pregnant or lactating women, or women planning to become pregnant during the study period
- Poorly controlled hypertension (defined as: systolic blood pressure > 150 mmHg and/or diastolic blood pressure >100 mmHg)
- Bleeding, thrombotic illness, or use of an anticoagulant (e.g., warfarin) or similar drug requiring therapeutic INR monitoring within 6 months prior to the first administration of the study drug
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
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, MD, 86-21-641755901105, zhimingshao@yahoo.com
Ruoxi Wang, MD, 86-21-641755901105, 08301010259@fudan.edu.cn
About this study
This review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- epirubicin,cyclophosphamide,paclitaxel,Carrelizumab, epirubicin,cyclophosphamide,paclitaxel
- 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.
epirubicin,cyclophosphamide,paclitaxel,CarrelizumabDrug
Conventional chemotherapy in combination with carrelizumab
epirubicin,cyclophosphamide,paclitaxelDrug
Conventional chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | SHR1210 (carrelizumab): 200 mg in combination with chemotherapy (described below) intravenously (IV), Q2W, and famitinib (10 mg) orally once daily (QD). This was followed by maintenance therapy with SHR1210 (carrelizumab) (200 mg, IV every 2 weeks [Q2W]) and famitinib (10 mg) orally once daily (QD) to complete treatment with a total duration of 1 year from the first dose.
Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel（80 mg/m2）or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks. Receives: Drug: epirubicin,cyclophosphamide,paclitaxel,Carrelizumab |
| Arm-B | Sham comparator | Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel（80 mg/m2）or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks. Receives: Drug: epirubicin,cyclophosphamide,paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
iDFS
invasive disease-free survival
Measured: 5 years
Secondary outcomes (2)
DDFS
distant disease-free survival
Measured: 5 years
OS
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jun 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 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 Fudan UniversityThe 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
- 606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862064
- Sponsor's protocol ID
- BCTOP-T-A02
- Status last verified
- Jul 2025
- First submitted
- 7 May 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05862064
- Acronym / sponsor ID
- BCTOP-T-A02
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 17 May 2023 (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.
This review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Drug: epirubicin,cyclophosphamide,paclitaxel,CarrelizumabSHR1210 (carrelizumab): 200 mg in combination with chemotherapy (described below) intravenously (IV), Q2W, and famitinib (10 mg) orally once daily (QD). This was followed by maintenance therapy with SHR1210 (carrelizumab) (200 mg, IV every 2 weeks [Q2W]) and famitinib (10 mg) orally once daily (QD) to complete treatment with a total duration of 1 year from the first dose. Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel（80 mg/m2）or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks. |
| Arm-B | Sham comparator | Drug: epirubicin,cyclophosphamide,paclitaxelChemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel（80 mg/m2）or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign the Informed Consent Form (ICF)
- The patient is judged by the investigator to have the ability to comply with the provisions of the protocol
- Women aged 18~70 at the time of signing the ICF
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0
Key exclusion criteria (22 listed)
- Have a history of invasive breast cancer
- T4 clinical tumors as specified in the UICC/AJCC Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer
- For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer RT, except for treatments planned under this study condition
- Previous treatment with anthracyclines or taxane for any malignant tumor
- History of DCIS and/or LCIS, treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or RT, followed by invasive cancer, patients treated with DCIS/LCIS only surgery and/or RT for contralateral DCIS may be enrolled in the study.
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 |
|---|---|---|
| epirubicin,cyclophosphamide,paclitaxel,CarrelizumabConventional chemotherapy in combination with carrelizumab | Drug | Arm-A |
| epirubicin,cyclophosphamide,paclitaxelConventional chemotherapy | Drug | Arm-B |
Primary outcome
iDFS
Time frame: 5 years
invasive disease-free survival
2 secondary outcomes
DDFS
Time frame: 5 years
OS
Time frame: 5 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 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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 epirubicin,cyclophosphamide,paclitaxel,Carrelizumab and epirubicin,cyclophosphamide,paclitaxel in people with TNBC - Triple-Negative Breast Cancer, run by Fudan University 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 22 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 Jul 2025. 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. Some participants in this study may receive a placebo. 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 Zhimin Shao, MD,PhD (+86-021-64175590 ext. 88700, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (time frame: 5 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 16 Jul 2025.