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

Phase 2

Completed

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

• Registration Number: NCT03140553
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-25
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EC-TH	TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)	epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab
TCH	TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)	docetaxel/carboplatin/trastuzumab

Primary Outcome Measures

Name	Time	Method
pCR	one year	pathologic complete response

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China