ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC
Breast Cancer, Neoadjuvant Chemotherapy
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Human epidermal growth factor receptor 2, Pathology complete response
Eligibility Criteria
Inclusion Criteria:
- Adult patient, >/= 18 years of age, </= 70 years of age.
- HER2-positive breast cancer
- Histologically confirmed invasive breast carcinoma
- Clinical stage T2-4/N0-3/M0 or node positive at presentation (patients with T1 tumors will not be eligible)
- Known hormone-receptor status
- Non previous anti-breast cancer neoadjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic, renal and liver function
- Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO)
- Adequate organ function
Exclusion Criteria:
- Stage IV (metastatic) breast cancer or bilateral breast cancer
- History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ)
- History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
- Cardiopulmonary dysfunction as defined by protocol
- Current severe, uncontrolled systemic disease
- Pregnant or lactating women
- Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
- Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
- History of intolerance, including Grade 3 to 4 infusion reaction or
- hypersensitivity to trastuzumab or chemotherapy drugs
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ACHP-THP
EC-THP
Doxorubicin liposome(PLD)35 mg/m2 Cyclophosphamide(CTX)600 mg/m2 Trastuzumab:first cycle 8mg/kg,then 6mg/kg Pertuzumab:first cycle 840mg,then 420mg Docetaxel(DOC)75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
Epirubicin(EPI)90 mg/m2 Cyclophosphamide(CTX)600 mg/m2 Trastuzumab:first cycle 8mg/kg,then 6mg/kg Pertuzumab:first cycle 840mg,then 420mg Docetaxel(DOC)75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week