Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)
- Conditions
- Breast CancerTriple Negative Breast Cancer
- Interventions
- Drug: Antivascular therapyDrug: Chemotherapy
- Registration Number
- NCT05909332
- Lead Sponsor
- Fudan University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 548
- 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.
- Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy)
- Has bilateral breast cancer;
- Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (a cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous to randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- Is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has known allergy to taxane and excipients.
- Has severe or uncontrolled infection;
- Has a history of psychotropic substance abuse and was unable to abandon drug habits or those with a history of mental disorders;
- the researchers judged patients to be unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm-A Chemotherapy 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. Arm-B Chemotherapy 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. Arm-A Antivascular therapy 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.
- Primary Outcome Measures
Name Time Method iDFS 5 years invasive disease-free survival
- Secondary Outcome Measures
Name Time Method DRFS 5 years distant recurrence free survival
OS 5 years overall survival
AE 5 years adverse effects
Trial Locations
- Locations (15)
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangdong, Guangzhou, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Breast cancer institute of Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China