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

Launched by FUDAN UNIVERSITY · Jun 11, 2023

Keywords

ClinConnect Summary

The BCTOP-T-A03 clinical trial is studying a new treatment approach for women with triple-negative breast cancer, a type of breast cancer that does not respond to certain hormone therapies. This trial will compare the effects of adding a special therapy that targets blood vessels (called antivascular therapy) to standard chemotherapy, versus using chemotherapy alone. The goal is to find out if the combination treatment helps patients do better after their surgery.

To participate in this trial, women aged 18 to 70 who have had surgery for stage IIA-IIIIC triple-negative breast cancer may be eligible, as long as they meet certain health criteria. Participants can expect to receive either the new combination treatment or standard chemotherapy and will be monitored closely throughout the study. It’s important to note that women who are pregnant, breastfeeding, or unable to use effective birth control are not eligible. This study is actively recruiting participants, and those who join will contribute to important research that could improve future treatment options for breast cancer.

Gender

FEMALE

Eligibility criteria

• 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.