Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer
Breast Cancer, Neoadjuvant Chemotherapy
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy
- Patients have enough tissue sample to do IHC test for subtype classification
- Patients have at least one measurable lesion according to RECIST1.1
- KPS≥80
- No prior treatment for breast cancer
- Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine <1.5 times the upper limit of normal [ULN] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.
Exclusion Criteria:
- Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
- Previous chemotherapy for breast cancer.
- history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for >10 years).
Sites / Locations
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Luminal subtype test
Luminal subtype control
Her2 positive subtype test
Her2 positive subtype control
Triple negative subtype test
Triple negative subypte control
Paclitaxel 175mg/m2, every 2 weeks as a cycle for 4-6 cycles
Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles
Paclitaxel 175mg/m2 plus carboplatin AUC 4 with or without trastuzumab every 2 weeks as a cycle for 4-6 cycles
Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 with or without trastuzumab every 3 weeks as a cycle for 4-6 cycles
Paclitaxel 175mg/m2 plus carboplatin AUC 4 every 2 weeks as a cycle for 4-6 cycles
Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles