Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: epoetin alfa; filgrastim; cyclophosphamide; doxorubicin hydrochloride; epirubicin hydrochloride; fluorouracil; paclitaxel
Intervention description: 40,000 IU; 5 mg/kg/d - days 2-13; 75, 600 and 830 mg/m2; 60 mg/m2; 60 mg/m2; 500mg/m2; 175 mg/m2
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Fluorouracil; Epirubicin; Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2104.0
Sex: Female
Maximum age: 60 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Summary:

      RATIONALE:

        1. . To compare the effects on breast cancer of three different combinations of drugs which
           are commonly used to treat this disease.

        2. . It is not yet known which treatment regimen is most effective for breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      given with or without epoetin alfa in treating women who have undergone surgery for stage I,
      stage II, or stage III breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the breast that is potentially curable

               -  T0-4 (dermal involvement on pathology assessment only), N0-2, M0

               -  No clinical T4 disease

          -  Previously treated with one of the following:

               -  Total mastectomy and level II axillary node dissection

               -  Partial mastectomy and level II axillary node dissection with planned breast
                  radiotherapy after completion of adjuvant chemotherapy regimen*

               -  Patients with a positive sentinel node biopsy must undergo level II axillary node
                  dissection or sufficient nodal sampling

               -  If microscopic residual in situ or invasive disease is present at total or
                  partial mastectomy margins, planned radiotherapy must also include a boost to the
                  tumor bed

          -  No residual tumor in the axilla after dissection

          -  Axillary node positive

               -  Negative nodes allowed if the tumor is ≥ 1 cm and 1 or more of the following
                  criteria defining high-risk node-negative disease are met:

                    -  Histological grade III or,

                    -  Estrogen receptor negative or,

                    -  Lymphatic/vascular invasion

          -  Hormone receptor status:

               -  Estrogen receptor status known

        PATIENT CHARACTERISTICS:

        Age:

          -  60 and under

        Sex:

          -  Female

        Menopausal status:

          -  Pre- or postmenopausal

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  At least 5 years

        Hematopoietic:

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic:

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

        Renal:

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular:

          -  LVEF ≥ limit of normal by MUGA or echocardiogram

          -  No arrhythmia requiring ongoing treatment

          -  No congestive heart failure

          -  No documented coronary artery disease

        Other:

          -  No other malignancy except:

               -  Adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
                  of the cervix

               -  Ductal or lobular carcinoma in situ that has been curatively treated by surgery
                  alone

               -  Other prior malignancies (except breast cancer) curatively treated more than 5
                  years prior to study entry

          -  No serious underlying medical illness or psychiatric or addictive disorder that would
             preclude study compliance

          -  No known hypersensitivity to E. coli-derived products, mammalian-cell derived
             products, or any study agents

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective non-hormonal contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for breast cancer

          -  No concurrent pegfilgrastim or darbepoetin alfa (Arm II)

               -  Allowed on arms 1 and 3 if medically necessary

        Chemotherapy:

          -  No prior chemotherapy for breast cancer

        Endocrine therapy:

          -  No prior hormonal therapy for breast cancer

          -  No concurrent hormone replacement therapy

          -  No concurrent selective estrogen-receptor modulators (e.g., raloxifene for the
             treatment or prevention of osteoporosis)

          -  No concurrent oral contraceptives (i.e., birth control pills)

          -  No other concurrent aromatase inhibitors

        Radiotherapy:

          -  See Disease Characteristics

          -  No prior radiotherapy for breast cancer

        Surgery:

          -  See Disease Characteristics

          -  No more than 12 weeks since prior total or partial mastectomy (including re-excision
             of margins)

        Other:

          -  At least 30 days since prior investigational drugs

          -  No other concurrent investigational drugs

          -  Concurrent bisphosphonates for the treatment or prevention of osteoporosis allowed