Antivascular Therapy plus Chemo for Triple Negative Breast Cancer
Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)
Recruiting
Phase 3Interventional Study
Breast CancerTriple Negative Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
764 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for women with a specific type of breast cancer called triple-negative breast cancer. Participants will receive a new treatment combined with standard chemotherapy to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18-70 years old
I have been diagnosed with triple-negative breast cancer
I have stage IIA-IIIIC breast cancer that is not spread to other parts of my body
I have a good performance status (ECOG score of 0 or 1)
I have received surgery for my cancer and my incision has healed
I have normal blood test results
I can use effective contraception if I am able to get pregnant
I can follow the study's rules as determined by the doctor
You may not be able to join if
I have received chemotherapy or radiation before this study
I have breast cancer in both breasts
I have a history of other cancers, except for some skin cancers
I have stage 4 breast cancer or more advanced
I have severe issues with my organs or heart
I am pregnant or breastfeeding
I have an allergy to taxane
I have a serious infection or mental health issues that would prevent me from participating
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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-negativ…
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.
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