Breast Cancer, Triple Negative Breast Cancer
Conditions
Keywords
triple negative breast cancer, adjuvant therapy, antivascular therapy
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.
Interventions
DRUGAntivascular therapy
BP102 (anti VEGFR)
DRUGChemotherapy
ddEC-P
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iDFS | 5 years | invasive disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DRFS | 5 years | distant recurrence free survival |
| OS | 5 years | overall survival |
| AE | 5 years | adverse effects |
Countries
China
Contacts
CONTACTZhi-Ming Shao, MD, PhD
Outcome results
None listed