ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC

Phase

Condition

Breast Cancer

Cancer

Chemotherapy

Treatment

Epirubicin

Paclitaxel-albumin

Trastuzumab

Clinical Study ID

NCT04172259

METIS

SCBCG-023

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 tumorswill 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

Exclusion Criteria:

Stage IV (metastatic) breast cancer or bilateral breast cancer
History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma insitu)
History of other malignancy within the last 5 years except for appropriately treatedcarcinoma 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, orsclerosing cholangitis
Concurrent serious uncontrolled infections requiring treatment or known infection withHIV
History of intolerance, including Grade 3 to 4 infusion reaction or
hypersensitivity to trastuzumab or chemotherapy drugs

Study Design

Epirubicin

January 10, 2019

September 30, 2026

Study 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.

We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients. So now we want to compare ACHP-THP regimen compared with the EC-THP regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy.

Connect with a study center

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
China
Site Not Available

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