ACH-TH vs EC-TH as Neoadjuvant Therapy for HER2-positive EBC

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    180
  • sponsor
    Sun Yat-sen University
Updated on 23 January 2021
cyclophosphamide
carcinoma
doxorubicin
HER2
docetaxel
trastuzumab
adjuvant therapy
erbb2
breast carcinoma
invasive breast cancer
her2/neu-positive breast cancer
epirubicin

Summary

Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy.

Description

Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab could improve the DFS rate in HER2+ EBC. But due to the cardio-toxicity of both anthracycline and trastuzumab, the investigators usually avoid using these two drugs synchronously. The guidelines do not recommend ECH-TH regemin because of cardiac adverse effect. Doxorubicin liposome(A) has equivalent effect as anthracycline in advaced breast cancer(ABC), lower cardiac toxicity and could be combined use with trastuzumab. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, Neoadjuvant Chemotherapy, breast carcinoma, cancer, breast
Treatment cyclophosphamide, docetaxel, Epirubicin, Trastuzumab, Doxorubicin liposome
Clinical Study IdentifierNCT04172259
SponsorSun Yat-sen University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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