Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer

Completed

Conditions studied: Breast Cancer, Perioperative/Postoperative Complications

In brief

RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer. PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage I or stage II breast cancer.

Key facts

Study ID

NCT00002762

Run by

Alliance for Clinical Trials in Oncology

People needed

1118

Starts

1996-06-01

Expected to finish

2009-10-01

Last updated by the study team

2016-07-12

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women age 18 to 55 years
• Regular menstrual cycles of 21- to 35-days duration
• Pathologic stages I to II breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure.
• required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure.

You may not qualify if…

• Lactation within the past 3 months
• galactorrhea
• neoadjuvant therapy
• previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years

Where it is running

• CCOP - Western Regional, Arizona — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Scripps Cancer Center at Scripps Clinic — La Jolla, California, United States
• Rebecca and John Moores UCSD Cancer Center — La Jolla, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Baptist Regional Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• CCOP - Mount Sinai Medical Center — Miami Beach, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• CCOP - Atlanta Regional — Atlanta, Georgia, United States
• Cancer Research Center of Hawaii — Honolulu, Hawaii, United States
• CCOP - Evanston — Evanston, Illinois, United States
• Rockford Clinic — Rockford, Illinois, United States
• Community Regional Cancer Care — Indianapolis, Indiana, United States
• CCOP - Wichita — Wichita, Kansas, United States
• Eastern Maine Medical Center — Bangor, Maine, United States
• Franklin Square Hospital Center — Baltimore, Maryland, United States
• Warren Grant Magnuson Clinical Center — Bethesda, Maryland, United States
• Cancer Research Center at Boston Medical Center — Boston, Massachusetts, United States
• Lahey Clinic Medical Center - Burlington — Burlington, Massachusetts, United States
• CCOP - Kalamazoo — Kalamazoo, Michigan, United States
• Hennepin County Medical Center - Minneapolis — Minneapolis, Minnesota, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• Keesler Medical Center - Keesler Air Force Base — Keesler Air Force Base, Mississippi, United States
• CCOP - Kansas City — Kansas City, Missouri, United States
• MBCCOP - Gulf Coast — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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