Clinical trial · Interventional
Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer
A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally 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, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or stage IIIB 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| therapeutic surgical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Pathologic response rate
- measure
- Toxicity patterns
Secondary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Stage IIIA or IIIB disease (T3 N1 M0, T4 N1 M0, any T N2/N3 M0) * Bidimensionally measurable or evaluable disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-2 * Platelet count ≥ 100,000 cells/μL * Total bilirubin normal * Hemoglobin ≥ 8.0 g/dL * ANC ≥ 1,000 cells/μL * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine clearance ≥ 50 mL/min and serum creatinine normal * Life expectancy ≥ 3 months * No uncontrolled infection * No chronic debilitating disease * No lack of physical integrity of the upper gastrointestinal tract * Able to swallow tablets * No malabsorption syndrome * No clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias \[New York Heart Association class III-IV heart disease\] or myocardial infarction within the last 12 months) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or adequately treated other noninvasive carcinomas * No peripheral neuropathy ≥ grade 1 PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior major surgery and recovered * No prior chemotherapy regimens including adjuvant therapy * No organ allograft * No concurrent sorivudine or bruvidine * No other concurrent cytostatic, cytotoxic, immunomodulating agents, or radiotherapy
References
Publications (0)
Data not yet available