EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: HER2 Positive Early Breast Cancer

Treatments: Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: cyclophosphamide; Drug: Epirubicin; Drug: carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05883852

SCHBCC-N055

Details and patient eligibility

About

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients

Full description

The objective of this study is to conduct a randomized controlled clinical study to compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients, so as to further optimize adjuvant chemotherapy regimen for breast cancer.

Enrollment: 1,406 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-70；
• 0-1 for ECOG；
• Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
• No gross or microscopic tumor remains after surgical resection；
• Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
• Postoperative pathological stage pT1-4N1-3M0；
• Did not receive neoadjuvant chemotherapy in the past；
• The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
• No peripheral neuropathy；
• Good postoperative recovery, at least 1 week interval between operation；
• The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；
• Contraception during treatment for women of reproductive age；
• Cardiac function: LVEF>50% for ultrasound examination；
• The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。

Exclusion criteria

• Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
• Have received chemotherapy for advanced disease；
• Transfer of any part；
• If any tumor >T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
• Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
• Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
• Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
• The patient has been enrolled in other clinical trials；
• Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
• LVEF<50% (cardiac ultrasound)；
• Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；
• Known allergy to related drugs；
• Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
• Pregnant and lactating women；
• Those who tested positive for pregnancy before taking the drug after joining the trial；
• Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；
• Persons without personal freedom and independent capacity for civil conduct。

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,406 participants in 2 patient groups

Arm A：TCbHP

Experimental group

Description:

Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.

Treatment:

Drug: Trastuzumab

Drug: Docetaxel

Drug: Pertuzumab

Drug: carboplatin

Arm B：EC-THP

Active Comparator group

Description:

Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.

Treatment:

Drug: Trastuzumab

Drug: Docetaxel

Drug: Epirubicin

Drug: Pertuzumab

Drug: cyclophosphamide