Clinical trial · Interventional
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB, stage IIIC, or stage IV primary breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HER2 over-expressing primary breast cancer group
- description
- Patients receive epirubicin hydrochloride and cyclophosphamide in week 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses. Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.
- interventionNames
- Biological: trastuzumab
- Drug: cyclophosphamide
- Drug: docetaxel
- Drug: epirubicin hydrochloride
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
Primary outcomes (1)
- measure
- Pathological complete response
- timeFrame
- Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of primary breast cancer * Stage IIIB, IIIC, or IV disease * No inflammatory disease * HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization * Hormone receptor status known PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Performance status 0-1 * WBC ≤ 10,000/mm³ * Absolute neutrophil count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.5 g/dL * SGOT/SGPT ≤ 60 IU/L * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * LVEF ≥ 55% * No signs of pneumonitis PRIOR CONCURRENT THERAPY: * No prior surgery except for biopsy * No prior or concurrent chemotherapy and/or hormonal therapy * No prior or concurrent biological therapy * No prior or concurrent radiotherapy except postoperative radiotherapy
References
Publications (0)
Data not yet available