Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed resectable adenocarcinoma of the breast

pT1, pT2, pT3, or minimal dermal involvement on pathology only

pN0, pN1, pN2, or M0

Negative nodal status

At least 8 nodes are negative

Unknown nodal status

Less than 8 nodes examined and no pathological finding

Positive nodal status

Any positive finding independent of the number of nodes examined
Negative sentinel node or no prior nodal dissection allowed if all other criteria met

Must have had total mastectomy, lumpectomy, or quadrantectomy

Should have prior chest wall radiotherapy after segmental mastectomy or histopathologic T4 dermal involvement
Stage I, II, or IIIa allowed if the tumor is completely removed macroscopically and margins of the resected tumor are microscopically free of tumor
Must undergo chest wall radiotherapy or second resection if microscopic disease at the mastectomy margins
No bilateral disease except in situ disease, either ductal or lobular of the contralateral breast

Postmenopausal

Regardless of prior hormonal replacement therapy (HRT) or hysterectomy:

Bilateral oophorectomy and any age
Radiologic castration and amenorrheic for at least 3 months and any age
Not postmenopausal at the start of adjuvant chemotherapy AND and completed at least 6 courses of prior cyclophosphamide, methotrexate, and fluorouracil (CMF) or at least 4 courses of prior anthracycline-cyclophosphamide continuation therapy and at least age 45 with follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) postmenopausal levels

No prior HRT:

Prior hysterectomy and less than age 55 with FSH/LH/E2 postmenopausal levels
Prior hysterectomy and at least age 55

No prior HRT or hysterectomy:

Amenorrhea more than 1 year and less than age 50
Amenorrhea more than 6 months and at least age 50

Prior HRT regardless of hysterectomy:

At least 1 month since prior HRT and less than age 55 with FSH/LH/E2 postmenopausal levels
At least 1 month since prior HRT and at least age 55
FSH/LH/E2 postmenopausal levels and uncategorized
No distant metastases, including bone scans showing hot spots unconfirmed as benign disease or skeletal pain of unknown cause
At least 10% hormone receptor-positive tumor cells

Hormone receptor status:

Estrogen receptor positive AND/OR
Progesterone receptor positive

PATIENT CHARACTERISTICS:

Age:

30 and over

Sex:

Female

Menopausal status:

Postmenopausal

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 10 g/dL

Hepatic:

Bilirubin less than 3.0 mg/dL
SGOT or SGPT less than 1.5 times upper limit of normal
No hepatic disease that would preclude study

Renal:

Creatinine less than 1.8 mg/dL
No renal disease that would preclude study

Cardiovascular:

No cardiovascular disease that would preclude study
Prior deep vein thrombosis allowed if medically stable

Pulmonary:

No lung embolism

Other:

No other prior or concurrent malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
No prior noncompliance to medical regimens
No other nonmalignant systemic diseases that would preclude follow-up
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior immunotherapy or biological response modifiers (e.g., interferon) allowed

Chemotherapy:

See Disease Characteristics
Prior adjuvant or neoadjuvant chemotherapy allowed
Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

See Disease Characteristics
Prior neoadjuvant hormonal therapy allowed (e.g., antiestrogens, progestins, or aromatase inhibitors) if no more than 4 months duration and no disease progression
Prior corticosteroids allowed
At least 4 weeks since prior HRT
Prior adjuvant antiestrogen therapy allowed if less than 1 month duration and immediately after surgery, radiotherapy, and/or chemotherapy
Prior antiestrogens for chemoprevention allowed if at least 18 months between completion of chemoprevention and diagnosis
No other concurrent antiestrogens or aromatase inhibitors
No concurrent raloxifene
No concurrent systemic HRT with or without progestins of more than 3 months duration

Radiotherapy:

See Disease Characteristics
Concurrent radiotherapy allowed

Surgery:

See Disease Characteristics

Other:

At least 30 days since prior systemic investigational drugs
At least 7 days since prior topical investigational drugs
Concurrent bisphosphonates allowed