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OpenTrials
Completed

NCT Number: NCT00002762

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Michael's Hospital - Toronto, Toronto, Ontario, Canada

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About this study

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.

Premenopausal women age 18 to 55 years, who were interviewed for menstrual history and who were surgically treated for stages I to II breast cancer, had serum drawn within 1 day of surgery for estradiol, progesterone, and luteinizing hormone levels. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. Disease-free survival (DFS) and overall survival (OS) rates were determined by Kaplan-Meier method and were compared by using the log-rank test and Cox proportional hazard modeling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

patient interviewing to obtain menstrual history

Behavioral

blood sampling

Procedure

Primary outcomes

  1. disease-free survival

    Time frame: Up to 5 years

  2. overall survival

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • NSABP Foundation Inc
  • National Cancer Institute (NCI)

Registry information

Official study title

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Important dates

Study start
1996
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2003
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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