Combining antivascular therapy with chemotherapy for treating triple-negative breast cancer

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)

This study is testing if adding a new type of treatment that targets blood vessels to standard chemotherapy can help women with triple-negative breast cancer do better after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 764 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 15 sites (Beijing, Beijing Municipality and 14 other locations)
• Trial ID: NCT05909332 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial is a randomized, open-label study that evaluates the effectiveness of antivascular therapy in combination with standard chemotherapy compared to chemotherapy alone in the adjuvant treatment of patients with triple-negative breast cancer, specifically the basal-like/immune suppressed subtype. The trial aims to determine if the addition of antivascular therapy can improve patient outcomes in this challenging cancer type. Eligible participants include women aged 18-70 with specific histological characteristics and adequate organ function.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-70 with stage IIA-IIIIC triple-negative breast cancer who have undergone surgical treatment.

Not a fit: Patients with metastatic triple-negative breast cancer or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with triple-negative breast cancer.

How similar studies have performed: While there have been studies exploring antivascular therapies, this specific combination approach in the context of triple-negative breast cancer is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality and 14 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangdong, Guangzhou, China (Recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Breast cancer institute of Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Zhi-Ming Shao, MD, PhD

Conditions Breast Cancer; Triple Negative Breast Cancer; triple negative breast cancer; adjuvant therapy; antivascular therapy