A CLINICAL TRIAL TO DETERMINE THE EFFICACY OF A DIETARY FAT REDUCTION PROGRAM PROVIDED IN ADDITION TO SYSTEMIC ADJUVANT THERAPY IN THE MANAGEMENT OF PATIENTS WITH PRIMARY INVASIVE BREAST CANCER

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven, invasive, localized carcinoma of the
breast Stage I/II/IIIA disease, i.e.: Tumor confined to breast on clinical examination
Overlying skin movable with respect to tumor Tumor movable in relation to underlying
muscle and chest wall Bone scan and/or x-ray required to rule out bone metastases in cases
of skeletal pain Tumor size requirements: No greater than 5 cm if lymph nodes are positive
Greater than 1 cm if lymph nodes are negative Tumor definitively treated by one of the
following procedures: Total mastectomy with axillary node dissection Segmental mastectomy
with or without axillary node dissection and/or sentinel node biopsy followed by breast
irradiation, provided: Surgical margins are histologically free of invasive or noninvasive
tumor One additional resection allowed to obtain clear margins Total mastectomy required
if clear margins are not obtained at second resection The following conditions exclude:
Bilateral malignancy or any mass in the contralateral breast unless proven nonmalignant by
biopsy Palpable lymph nodes in the contralateral axilla or probable supraclavicular or
infraclavicular nodal involvement unless proven nonmalignant by biopsy 10 or more positive
lymph nodes Inflammatory breast cancer Ulceration or erythema Infiltration of the skin or
peau d'orange Tethering or dimpling of the skin or nipple inversion should not be
considered skin infiltration Satellite breast nodules Parasternal nodules Edema of the arm
Hormone receptor status: Any estrogen receptor (ER) or progesterone receptor (PR) status
allowed ER assessment required PR assessment recommended Less than 365 days between
definitive surgery and randomization

PATIENT CHARACTERISTICS: Age: 48 to 78 Sex: Female Menopausal status: Postmenopausal
Performance status: Not specified Life expectancy: At least 10 years (excluding breast
cancer) Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL AST no greater than 60 IU/mL (or within 2 times
normal) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active cardiac
disease that would preclude doxorubicin in patients assigned to adjuvant chemotherapy with
doxorubicin Other: Baseline caloric intake at least 20% fat Accessible for follow-up and
by telephone Sufficient memory required to provide food recall data Must speak and read
English Medically and nutritionally eligible for either dietary intervention arm No prior
or concomitant malignancy except curatively treated nonmelanoma skin cancer or carcinoma
in situ of the cervix

PRIOR CONCURRENT THERAPY: No concurrent participation in another adjuvant breast cancer
trial that has disease-free or overall survival as a study endpoint (e.g., a major
cooperative group trial) Biologic therapy: Not specified Chemotherapy: Concurrent adjuvant
cyclophosphamide, methotrexate, fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), AC
followed by paclitaxel, or fluorouracil/doxorubicin/cyclophosphamide (FAC, CAF) allowed If
ER negative, approved chemotherapy regimen and/or tamoxifen required No more than 120 days
between definitive surgery and initiation of adjuvant systemic chemotherapy Endocrine
therapy: Concurrent adjuvant tamoxifen required if ER positive (if ER negative, tamoxifen
and/or an approved chemotherapy regimen required) No more than 180 days between definitive
surgery and initiation of tamoxifen (if receiving tamoxifen alone) If receiving adjuvant
CMF, AC, or FAC, CAF, or AC, paclitaxel, tamoxifen begins after completion of adjuvant
therapy Radiotherapy: Radiotherapy required within 56 days following segmental mastectomy
Surgery: Definitive surgery required Prior oophorectomy for reasons other than malignancy
allowed