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MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER


N/A
18 Years
55 Years
Not Enrolling
Female
Breast Cancer, Perioperative/Postoperative Complications

Thank you

Trial Information

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER


OBJECTIVES:

- Document menstrual phase (follicular vs luteal) by circulating hormones and menstrual
history at the time of primary surgery in premenopausal women with stage I or II breast
cancer.

- Correlate menstrual phase at primary surgery with 5-year disease-free survival in these
patients.

- Compare the menstrual cycle data obtained by hormone levels and study-specific
menstrual cycle history with information recorded in the general written record.

- Compare the menstrual cycle data (e.g., hormone levels and cycle history) for these
women with the data for the general population.

- Estimate the disease-free survival of women who undergo a 2-stage surgical procedure
with cancer found at both stages when the surgery is not confined to the same menstrual
cycle phase.

OUTLINE: This is a multicenter study.

Hormone levels and menstrual history are obtained within one calendar day to surgery.

Patients undergo either one- or two-stage surgery (open biopsy followed immediately or later
by mastectomy or breast-conserving surgery).

Patients complete a questionnaire 6 months after surgery to assess the extent of adjuvant
therapy received (if any) and a questionnaire 12 months after surgery to assess recurrence
of breast cancer and vital status.

Patients are followed annually for 10 years.

PROJECTED ACCRUAL: A total of 1,100 patients will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage I or II breast cancer

- No prior breast cancer

- Must have regular menstrual cycles (21-35 days)

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 to 55

Sex:

- Female

Menopausal status:

- Premenopausal

Performance status:

- Not specified

Life expectancy:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant

- No nursing within the past 3 months

- No galactorrhea

- No prior malignancy within the past 10 years except squamous cell or basal cell skin
cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Concurrent chemotherapy allowed

Endocrine therapy:

- At least 3 months since prior oral contraceptives

Radiotherapy:

- Concurrent radiotherapy allowed

Surgery:

- Complete surgical resection required prior to entry

- One- or two-stage procedure (e.g., open biopsy followed immediately or later by
mastectomy or breast-conserving approach)

- Two-step registration required for patients undergoing two-stage procedure

- Fine-needle aspiration (FNA), stereotactic, or core-needle biopsy is allowed at any
time prior to open biopsy

- Sentinel node dissection/axillary node dissection allowed

Other:

- No prior neoadjuvant therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Clive S. Grant, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000064717

NCT ID:

NCT00002762

Start Date:

June 1996

Completion Date:

Related Keywords:

  • Breast Cancer
  • Perioperative/Postoperative Complications
  • stage I breast cancer
  • stage II breast cancer
  • perioperative/postoperative complications
  • Breast Neoplasms
  • Postoperative Complications

Name

Location

Akron City HospitalAkron, Ohio  44304
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Newark Beth Israel Medical CenterNewark, New Jersey  07112
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - EvanstonEvanston, Illinois  60201
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Hartford HospitalHartford, Connecticut  06102-5037
Rockford ClinicRockford, Illinois  61103
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
South Pointe HospitalCleveland, Ohio  44122
CCOP - OklahomaTulsa, Oklahoma  74136
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Kent County Memorial HospitalWarwick, Rhode Island  02886
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Community Regional Cancer CareIndianapolis, Indiana  46219
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Scripps Cancer Center at Scripps ClinicLa Jolla, California  92037
Warren Grant Magnuson Clinical CenterBethesda, Maryland  20892-1182
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
St. Luke's Hospital and Health Network - BethlehemBethlehem, Pennsylvania  18015
Wellspan Health - York Cancer CenterYork, Pennsylvania  17403
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449