A Randomized, Open-label Phase III Clinical Trial Comparing Antivascular Therapy Combined With Standard Chemotherapy and Standard Chemotherapy in Adjuvant Therapy for Patients With Triple-Negative Breast Cancer, Basal-like Immunosuppressed Subtype (BCTOP-T-A03)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Women aged 18-70 years old;
• Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1;
• Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC;
• Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0;
• 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); Platelet count ≥ 75×109/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula);
• The surgical incision had fully healed prior to the commencement of the study;
• Female participants of reproductive potential are required to use a medically accepted form of contraception during the course of the study treatment and for at least three months following the last administration of the investigational drug;
• 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.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangdong
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
Breast cancer institute of Fudan University Cancer Hospital
RECRUITING
Shanghai
Shanghai First Maternity and Infant Hospital
RECRUITING
Shanghai
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
The First Hospital of China Medical University
RECRUITING
Shenyang
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Northern Jiangsu People's Hospital
RECRUITING
Yangzhou
Contact Information
Primary
Zhi-Ming Shao, MD, PhD
zhimingshao@yahoo.com
+86-021-64175590
Time Frame
Start Date:2023-06-20
Estimated Completion Date:2031-05-30
Participants
Target number of participants:548
Treatments
Experimental: Arm-A
BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose.~Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks.
Active_comparator: Arm-B
Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks.