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

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer; Neoadjuvant Chemotherapy

Treatments: Drug: Docetaxel; Drug: Trastuzumab; Drug: Doxorubicin liposome; Drug: Paclitaxel-albumin; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Paclitaxel; Drug: Pertuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04172259

SCBCG-023 (Other Identifier)

METIS

Details and patient eligibility

About

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.

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

ACHP-THP

Experimental group

Description:

Doxorubicin liposome（PLD）35 mg/m2 Cyclophosphamide（CTX）600 mg/m2 Trastuzumab：first cycle 8mg/kg，then 6mg/kg Pertuzumab：first cycle 840mg，then 420mg Docetaxel（DOC）75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week

Treatment:

Drug: Doxorubicin liposome

Drug: Trastuzumab

Drug: Pertuzumab

Drug: Cyclophosphamide

Drug: Docetaxel

Drug: Paclitaxel-albumin

EC-THP

Active Comparator group

Description:

Epirubicin（EPI）90 mg/m2 Cyclophosphamide（CTX）600 mg/m2 Trastuzumab：first cycle 8mg/kg，then 6mg/kg Pertuzumab：first cycle 840mg，then 420mg Docetaxel（DOC）75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week

Treatment:

Drug: Trastuzumab

Drug: Pertuzumab

Drug: Epirubicin

Drug: Cyclophosphamide

Drug: Docetaxel

Drug: Paclitaxel

Drug: Paclitaxel-albumin