Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

• Status: Completed
• Trial end date: 2014-03-17
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborators: Cancer and Leukemia Group B; North Central Cancer Treatment Group; Southwest Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Epirubicin; Epoetin Alfa; Fluorouracil; Lenograstim; Liposomal doxorubicin; Paclitaxel

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