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EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT05883852•Fudan University

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

FEMALE

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；
+4 more criteria

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)；
+7 more criteria

Locations (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 7, 2023

Primary Completion Date

July 1, 2031

Completion Date

July 1, 2031

Last Updated

June 27, 2023

Enrollment

1,406

ESTIMATED participants

Conditions

HER2 Positive Early Breast Cancer

Interventions

Docetaxel

DRUG

carboplatin

DRUG

Trastuzumab

DRUG

Pertuzumab

DRUG

Epirubicin

DRUG

cyclophosphamide

DRUG