Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: epirubicin; vinorelbine
Intervention description: Epirubicin (100 mg/m2) will be given on Day 1; Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Intervention MeSH terms: Vinorelbine; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 21 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IV breast cancer; male breast cancer

Summary:

      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.
    

Eligibility criteria:

        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