Actively Recruiting
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
Led by Fudan University · Updated on 2025-07-16
606
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Ability to follow the study protocol
- Female aged 18 to 70 years
- ECOG physical status score of 0 or 1
- Stage IIA to IIIC triple-negative breast cancer, non-metastatic, surgically treated (pT1-3N1-3M0)
- Histological confirmation of triple-negative status (negative HER2, ER, PgR)
- Adequate breast excision via breast-conserving surgery or mastectomy
- Pathological tumor-lymph node metastasis staging completed with SLNB and/or axillary lymph node dissection
- Surgery to randomization interval no more than 8 weeks
- Adequate hematological and organ function within 28 days prior to treatment
- For women of childbearing potential, agreement to use contraception or abstinence during and after treatment
- Willingness and ability to comply with scheduled visits and study procedures
You will not qualify if you...
- History of invasive breast cancer
- Clinical T4 tumors including inflammatory breast cancer
- Prior systemic anticancer therapy for current breast cancer
- Previous anthracycline or taxane treatment for any cancer
- History of DCIS/LCIS treated with systemic therapy or RT followed by invasive cancer (except certain contralateral DCIS cases)
- Cardiopulmonary dysfunction or severe cardiac conditions
- Prior malignancy within 5 years except treated in situ carcinoma or certain skin cancers
- History of severe allergies or hypersensitivity to study drugs or components
- Active or past autoimmune diseases or immunodeficiency (with some exceptions)
- Idiopathic pulmonary fibrosis or certain lung conditions
- Urinary obstruction
- Active tuberculosis
- Serious infections within 4 weeks prior to treatment
- Major surgery within 4 weeks before treatment or planned major surgery during study
- History of allogeneic stem cell or solid organ transplant
- Receipt of live attenuated vaccine within 4 weeks prior to treatment or expected during study
- Prior immune checkpoint or CD137 agonist therapy
- Recent systemic immunostimulant or immunosuppressive therapy
- Pregnant, lactating, or planning pregnancy during study
- Poorly controlled hypertension
- Bleeding or thrombotic illness or anticoagulant use requiring therapeutic monitoring within 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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