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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Zhi-Ming Shao, MD, PhD
• Email: zhimingshao@yahoo.com
• Phone: +86-021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.