TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer

Overview

Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) 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 of TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) 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.

Full Title of Study: “TCH (Docetaxel/Carboplatin/Trastuzumab) Versus EC -TH(Epirubicin/Cyclophosphamide Followed by Docetaxe/Trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 11, 2019

Interventions

  • Drug: TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)
    • TCH (docetaxel/carboplatin/trastuzumab) versus EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer

Arms, Groups and Cohorts

  • Experimental: TCH
    • docetaxel/carboplatin/trastuzumab
  • Active Comparator: EC-TH
    • epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab

Clinical Trial Outcome Measures

Primary Measures

  • pCR
    • Time Frame: one year
    • pathologic complete response

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically or cytologically confirmed HER2 positive invasive breast carcinoma – Clinical stage Ⅱ-ⅢC – 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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: KunWang, Professor – Guangdong Provincial People’s Hospital
  • Overall Official(s)
    • Kun Wang, MD, Principal Investigator, Guangdong Provincial People’s Hospital

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