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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


Phase 3
48 Years
78 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.

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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Daniel W. Nixon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000063537

NCT ID:

NCT00002564

Start Date:

April 1994

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Rhode Island HospitalProvidence, Rhode Island  02903
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Medical College of WisconsinMilwaukee, Wisconsin  53226
Cedars-Sinai Medical CenterLos Angeles, California  90048
Sharp Healthcare - MurrietaMurrieta, California  92562
Permanente Medical Group (060)Oakland, California  94611-5400
John Wayne Cancer InstituteSanta Monica, California  90404
Bennett Cancer CenterStamford, Connecticut  06902
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
Shands Cancer CenterGainesville, Florida  32610
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Palm Beach Oncology-Hematology at the Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Evanston Northwestern Health CareEvanston, Illinois  60201
Midwestern Regional Medical CenterZion, Illinois  60099
Women to WomenYarmouth, Maine  04096
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
St. Barnabas Medical CenterLivingston, New Jersey  07039
Surgical AssociatesAlbuquerque, New Mexico  87102
North Shore University HospitalManhasset, New York  11030
American Health FoundationNew York, New York  10017
Kaiser Permanente Center for Health ResearchPortland, Oregon  97227-1098
Spohn Hospital SouthCorpus Christi, Texas  78414
Texas Oncology, P.A.Dallas, Texas  75246