Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive adenocarcinoma of the breast

• Stage I, II or III disease

• pN+ or pN0 with grade III disease (tumor size ≥ 2 cm)

• No metastatic disease

• Must have undergone prior conservative or radical surgery that included axillary lymph node or sentinel node dissection

• No residual tumor

• Negative margins

• Hormone receptor status:

• Estrogen receptor and progesterone receptor negative

PATIENT CHARACTERISTICS:

• Female

• Postmenopausal

• Absolute neutrophil count > 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin > 10 g/dL

• Alkaline phosphatase < 2.5 times upper limit of normal (ULN)

• Bilirubin < 1.25 times ULN

• AST and ALT < 2.5 times ULN

• Creatinine clearance ≥ 40 mL/min

• No contraindication to receiving anthracyclines or alkalizing agents

• FEV normal

• Activities of Daily Living (ADL) score ≥ 5

• No decrease of ≥ 1 point within the past 3 months

• None of the following at baseline:

• Cognitive deficiency (Folstein Mini-Mental State < 25)

• Severe depression (Geriatric Depression Scale ≥ 20)

• Severe malnutrition (Mini-Nutritional Assessment ≤ 17)

• No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics grade 3-4), including any of the following:

• Cardiac insufficiency

• Unstable angina

• Myocardiopathy

• Myocardial infarction within the past year

• Uncontrolled hypertension

• Uncontrolled high-risk arrhythmia

• Severe medullary insufficiency

• Neurological or psychological condition that would preclude study consent

• Uncontrolled or active infection

• Severe urinary tract infection

• Preexisting hematuria

• Active ulcer

• Uncontrolled diabetes

• No other cancer within the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix

• No familial, geographical, social, or psychological condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 60 days since prior therapeutic surgery

• At least 4 weeks since prior investigational drugs