TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
This study is to evaluate the efficacy and safety ofTCHP
 (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by
 THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as
 Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete
 response is used as a surrogate marker for survival. Safety and tolerability assessed by
 number of grade 4 toxicities and hospitalizations.
Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by
 THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as
 Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN
 guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and
 safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by
 THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as
 Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete
 response is used as a surrogate marker for survival. Safety and tolerability assessed by
 number of grade 4 toxicities and hospitalizations.
Inclusion Criteria:

 -  • Histologically or cytologically confirmed HER2 positive invasive breast carcinoma

 -  Clinical stage #-#B

 -  Patients must have measurable disease as defined by palpable lesion with both
 diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound
 with at least one dimension ≥2cm. Bilateral mammogram and clip placement is
 required for study entry. Baseline measurements of the indicator lesions must be
 recorded on the Patient Registration Form. To be valid for baseline, the
 measurements must have been made within the 14 days if palpable. If not palpable,
 a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI
 must be done within 2 months prior to study entry. If clinically indicated, xrays
 and scans must be done within 28 days of study entry.

 -  Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days
 of study entry

 -  Normal (greater than 50%) left ventricular ejection fraction (LVEF) by
 echocardiography

 -  Signed informed consent

 -  Adequate organ function within 2 weeks of study entry:

 Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total
 bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate
 ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate
 transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline
 Phosphatase must be within the range allowing for eligibility

 -  Patients must be over 18 years old.

 -  Women of childbearing potential must have a negative serum pregnancy test performed
 within 7 days prior to the start of treatment

 -  Women of childbearing potential and men must agree to use adequate contraception
 (barrier method of birth control) prior to study entry and for the duration of study
 participation.

 Exclusion Criteria:

 -  • Metastatic disease

 -  Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent,
 targeted therapy or radiation therapy for current breast cancer. Patients with
 history of breast cancer greater than 5 years from initial diagnosis are eligible
 for the study. Patients may not have received anthracycline-based chemotherapy in
 the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if
 there were treated with surgery alone.

 -  History of previous or current malignancy at other sites with the exception of
 adequately treated carcinoma in-situ of the cervix or basal or squamous cell
 carcinoma of the skin. Patients with a history of other malignancies, who remain
 disease free for greater than five years are eligible.