Clinical trial NCT05883852: EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
Official title: A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carboplatin Plus Trastuzumab and Pertuzumab (TCbHP) in the Adjuvant Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: HER2 Positive Early Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 1406
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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。

Primary outcomes:
measure: iDFS
timeFrame: 5 years
Secondary outcomes:
measure: DRFS
timeFrame: 5 years
measure: OS
timeFrame: 5 years
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center Shanghai, China, 200032
state: Shanghai
Study officials:
References: