Clinical trial · Interventional
Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer
NCT00176488CI-TRIAL-00026596terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Competing studies
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin together with vinorelbine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving epirubicin together with vinorelbine works in treating patients with stage II, stage III, or stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin | Drug | Epirubicin | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sequential epirubicin/vinorelbine
- description
- For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
- interventionNames
- Drug: epirubicin
- Drug: vinorelbine
Primary outcomes (1)
- measure
- Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.
- timeFrame
- 10 years
Secondary outcomes (2)
- measure
- Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IIB (T3, N0), IIIA, IIIB, or IV breast carcinoma * Original tumor must be available for analysis of p53 status * Measurable disease, defined as any lesion that can be accurately measured in ≥ 1 dimension with longest diameter ≥ 20 mm using conventional techniques OR ≥ 10 mm with spiral CT scan * Stage IIIB disease will be assessed by clinical exam (monitoring skin changes as well as tumor size) * No visceral crisis (lymphangitic pulmonary spread, or liver or marrow replacement sufficient to cause significant organ dysfunction) * No untreated CNS metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-2 * Life expectancy ≥ 8 weeks * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Bilirubin normal * AST ≤ 3 times normal (≤ 5 times normal if liver metastases are present) * Creatinine ≤ 1.5 mg/dL * Ejection fraction ≥ lower limit of normal by MUGA scan or ECG * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No other malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * No pre-existing disease (i.e., cardiac, pulmonary, neurologic, or other disease) that the investigator judges to be clinically significant * No active infectious process, severe malnutrition, or intractable emesis PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * At least 3 weeks since prior radiotherapy * At least 3 weeks since prior chemotherapy * Maximum prior doxorubicin hydrochloride dose must be ≤ 300 mg/m² OR equivalent anthracycline (epirubicin hydrochloride) dose must be ≤ 540 mg/m² OR calculated total anthracycline dose must be ≤ 540 mg/m² (determined as 1.8 times total doxorubicin hydrochloride dose plus epirubicin hydrochloride dose) * No prior chemotherapy for metastatic disease * Prior adjuvant chemotherapy, radiotherapy, and/or hormonal therapy for breast cancer allowed * No concurrent radiotherapy except for brain metastases
References
Publications (0)
Data not yet available
No reference posted for this study.