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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Liposomal doxorubicin; Trastuzumab

Criteria

Inclusion Criteria:

• Adult patient, >/= 18 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