NCT05909332 Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)
| NCT ID | NCT05909332 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 764 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 764 participants in total. It began in 2023-06-20 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05909332 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05909332 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 764 participants.
Is NCT05909332 currently recruiting?
Yes, NCT05909332 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT05909332 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Fuzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT05909332 clinical trial?
NCT05909332 is sponsored by Fudan University. The trial plans to enroll 764 participants.
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