Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm-A BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose. Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. |
Drug: Antivascular therapy
BP102 (anti VEGFR)
Drug: Chemotherapy
ddEC-P
|
| Active Comparator: Arm-B Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. |
Drug: Chemotherapy
ddEC-P
|
Outcome Measures
Primary Outcome Measures
- iDFS [5 years]
invasive disease-free survival
Secondary Outcome Measures
- DRFS [5 years]
distant recurrence free survival
- OS [5 years]
overall survival
- AE [5 years]
adverse effects
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Women aged 18-70 years old; 2. Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1; 3. Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC; 4. Have stage
IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated:
pT1-3N1-3M0; 5. 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); 6. The surgical incision had fully healed prior to the commencement of the study; 7. 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; 8. 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) 2. Has bilateral breast cancer; 3. Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. 4. Has metastatic (Stage 4) breast cancer; 5. Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer); 6. 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; 7. Is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives; 8. Patients participating in other clinical trials at the same time; 9. Has known allergy to taxane and excipients. 10. Has severe or uncontrolled infection; 11. Has a history of psychotropic substance abuse and were unable to abandon drug habits or those with a history of mental disorders; 12. the researchers judged patients to be unsuitable for the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FUSCC-BLIS-ADJ