Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)

Phase 3

Recruiting

• Conditions: Breast Cancer; Triple Negative Breast Cancer
• Interventions: Drug: Antivascular therapy; Drug: 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

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-11
• Study First Posted: 2023-06-18
• Study Start: 2023-06-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20
• Primary Completion: 2029-05-30
• Study Completion: 2031-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 548

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangdong, Guangzhou, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute; 🇨🇳 Shenyang, Liaoning, China

Breast cancer institute of Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China

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