Comparing two chemotherapy regimens for HER2-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
This study is testing two different chemotherapy treatments to see which one works better for women with early-stage HER2-positive breast cancer after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1406 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05883852 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of two chemotherapy regimens, TCbHP and EC-THP, in women with HER2-positive early breast cancer. It is a randomized controlled study that will evaluate how well these treatments work in optimizing adjuvant chemotherapy for this patient population. Participants will receive either regimen after surgical resection of their tumors, and their responses will be monitored to determine which approach is more effective.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-70 with HER2-positive early breast cancer who have undergone surgical resection.
Not a fit: Patients who have received neoadjuvant chemotherapy or have significant peripheral neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with HER2-positive early breast cancer.
How similar studies have performed: Other studies have shown success with similar chemotherapy regimens in treating HER2-positive breast cancer, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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。
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center Shanghai, China, 200032 — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.