Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Invasive breast cancer confirmed by pathology evaluation of core biopsy
- Tumors must be ER/PgR status negative (immunohistochemistry(IHC) < 10%) and lack of HER2/neu overexpression or amplification as measured by local hospital pathology laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC < 3+, and FISH < 2.2) as described in the NCCN Guidelines
- Female between18 to 70 years of age, Eastern Cooperative Oncology Group(ECOG) Performance Status 0 or 1
- Early-stage TNBC or HER2 positive breast cancer according to the American Joint Committee on Cancer (AJCC) Staging Manual Clinical Stage IIA or IIB, Stage IIIA operable breast cancer
- Previously untreated
- Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin > 9 g/dL, platelets > 100,000/µL.)
- Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥≥ 3.0 g/dL, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x ULN.
Exclusion Criteria:
- ICH:ER/PgR status positive
- HER2 positive breast cancer Patients with reduced ejection fraction <50% are not eligible
- Patients with second malignancies
- Patients with bilateral breast cancer
- allergic constitution
Sites / Locations
- Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Neoadjuvant chemotherapy
postoperative chemotherapy
Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve(AUC4) d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. RECIST is used once every 2 cycles. Patients will finish 6 cycles preoperative chemotherapy when CR/partial response(PR)/stable disease(SD) by RECIST without serious adverse events.
Postoperative Chemotherapy:Standard chemotherapy regiments according to risk of recurrence: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH), EC/TC±H, and so on.