Clinical trial · Interventional
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
NCT05883852CI-TRIAL-00067550recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Positive Early Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A:TCbHP
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: carboplatin
- Drug: Trastuzumab
- Drug: Pertuzumab
- type
- ACTIVE_COMPARATOR
- label
- Arm B:EC-THP
- 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.
- interventionNames
- Drug: Docetaxel
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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。
References
Publications (0)
Data not yet available
No reference posted for this study.