Actively Recruiting
Multi-center, Randomized, Open-label Study Comparing PD-1 Inhibitor with Antivascular Therapy plus Anthracycline/Taxane Chemotherapy Versus Chemotherapy Alone in Operable Triple-negative Breast Cancer
Led by Fudan University · Updated on 2025-07-16
606
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining SHR1210 (Camrelizumab) and the antivascular drug Famitinib with anthracycline/taxane-based adjuvant chemotherapy compared to conventional chemotherapy alone in patients with early-stage high-risk triple-negative breast cancer (TNBC). This phase III, multi-center, randomized, open-label study focuses on women with operable TNBC to determine if the combined approach improves patient outcomes. Participants in the experimental group receive SHR1210 (200 mg intravenously every two weeks) and Famitinib (10 mg orally once daily) alongside intensive chemotherapy consisting of epirubicin and cyclophosphamide every two weeks for four doses, followed by weekly paclitaxel or albumin-paclitaxel for 12 weeks. Maintenance therapy with SHR1210 and Famitinib continues to complete one year of treatment. The comparator group receives the conventional chemotherapy regimen alone following the same schedule. During the study, participants undergo regular assessments including laboratory tests, physical exams, and monitoring for disease recurrence over five years. The primary outcome is invasive disease-free survival measured at five years. Secondary outcomes include distant disease-free survival and overall survival at five years. The study includes safety monitoring and requires adherence to scheduled visits and treatment protocols throughout the trial duration.
CONDITIONS
Brief 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 comply with study protocol
- Female aged 18 to 70 years
- ECOG physical status score of 0 or 1
- Stage IIA to IIIC triple-negative breast cancer with no metastasis, surgically treated
- Histology confirmed triple-negative breast cancer (negative HER2, ER, PgR)
- Underwent breast-conserving surgery or mastectomy
- Completed pathological tumor and lymph node staging
- Surgery to randomization interval within 8 weeks
- Adequate blood counts and organ function as defined by specific lab values
- Women of childbearing potential agree to effective contraception during and after treatment
- Willingness and ability to follow scheduled visits and procedures
You will not qualify if you...
- History of invasive breast cancer
- T4 tumors or inflammatory breast cancer
- Prior systemic anticancer therapy for current breast cancer
- Previous anthracycline or taxane treatment for any cancer
- History of DCIS or LCIS with systemic therapy followed by invasive cancer
- Significant cardiopulmonary dysfunction or recent myocardial infarction
- Prior malignancy within 5 years except certain low-risk cancers
- Severe allergic reactions to study drugs or related compounds
- Active or prior autoimmune disease or immunodeficiency except controlled hypothyroidism or type 1 diabetes
- History of pulmonary fibrosis or active pneumonia
- Urinary obstruction
- Active tuberculosis or serious infections within 4 weeks prior to treatment
- Recent major surgery or expected surgery during study
- History of stem cell or organ transplantation
- Recent live attenuated vaccination or expected vaccination during study
- Previous immune checkpoint or CD137 agonist therapy
- Recent use of systemic immunostimulants or immunosuppressants
- Pregnant or breastfeeding women, or planning pregnancy
- Poorly controlled hypertension
- Recent bleeding, thrombotic illness, or use of anticoagulants requiring monitoring
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months of chemotherapy followed by maintenance therapy up to 1 year for some participants
Participants receive anthracycline and taxane-based chemotherapy, with some also receiving PD-1 inhibitor and antivascular therapy, administered intravenously and orally according to their assigned group.
Chemotherapy: 4 intravenous doses every 2 weeks followed by weekly infusions for 12 weeks; Maintenance therapy: intravenous infusion every 2 weeks and daily oral medication
Duration - Up to 5 years after treatment
Participants are monitored for disease outcomes and overall survival after completing treatment.
Periodic visits as scheduled for long-term monitoring
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
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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