RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat may help fight cancer. PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been completely removed by surgery.

Condition	Treatment or Intervention	Phase
prevention of breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer	Behavior: Low-fat diet with counseling  Behavior: USDA/DHHS-approved diet	Phase III

Further Study Details: 

OBJECTIVES: I. Determine whether dietary fat reduction will effectively prolong disease-free and overall survival in women surgically treated for early stage breast cancer who are receiving adjuvant therapy with or without either tamoxifen, cyclophosphamide, methotrexate, fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF), or AC followed by paclitaxel. II. Evaluate whether differences in the lipid profile are associated with dietary group assignment and dietary fat.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, nodal status, ER status, and type of adjuvant chemotherapy. The first group receives intensive dietary intervention for reduction of total fat intake to 15% of calories, with repeated individual and group counseling sessions. The second group receives USDA/DHHS dietary guidelines and minimal intervention. All patients who are estrogen receptor positive receive concurrent therapy with tamoxifen; cyclophosphamide, methotrexate, fluorouracil (CMF) followed by tamoxifen; doxorubicin, cyclophosphamide (AC) followed by tamoxifen; fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF) followed by tamoxifen; or AC, paclitaxel followed by tamoxifen. Patients are followed annually throughout the study.

PROJECTED ACCRUAL: Approximately 2,500 women will be accrued for this study.

Ages Eligible for Study:  48 Years   -   78 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      John Wayne Cancer Institute, Santa Monica,  California,  90404,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Permanente Medical Group (060), Oakland,  California,  94611-5400,  United States
      Sharp Healthcare - Murrieta, Murrieta,  California,  92562,  United States
Connecticut
      Bennett Cancer Center, Stamford,  Connecticut,  06902,  United States
District of Columbia
      Lombardi Cancer Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
Florida
      Baptist Regional Cancer Institute - Jacksonville, Jacksonville,  Florida,  32207,  United States
      Palm Beach Oncology-Hematology at the Good Samaritan Medical Center, West Palm Beach,  Florida,  33401,  United States
      Shands Cancer Center, Gainesville,  Florida,  32610,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      Evanston Northwestern Health Care, Evanston,  Illinois,  60201,  United States
      Midwestern Regional Medical Center, Zion,  Illinois,  60099,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Maine
      Women to Women, Yarmouth,  Maine,  04096,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
Minnesota
      Virginia Piper Cancer Institute, Minneapolis,  Minnesota,  55407,  United States
New Jersey
      St. Barnabas Medical Center, Livingston,  New Jersey,  07039,  United States
New Mexico
      Surgical Associates, Albuquerque,  New Mexico,  87102,  United States
New York
      American Health Foundation, New York,  New York,  10017,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
Oregon
      Kaiser Permanente Center for Health Research, Portland,  Oregon,  97227-1098,  United States
Pennsylvania
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Texas
      Spohn Hospital South, Corpus Christi,  Texas,  78414,  United States
      Texas Oncology, P.A., Dallas,  Texas,  75246,  United States
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

Study chairs or principal investigators

Daniel W. Nixon,  Study Chair,  American Health Foundation   

Study ID Numbers:  CDR0000063537; AHF-WINS; NCI-H94-0001; MRMC-CTCA-9604; WINS-1
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002564
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08