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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NSABP Foundation Inc
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002762
First received: November 1, 1999
Last updated: July 11, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention
Breast Cancer
Perioperative/Postoperative Complications
Behavioral: patient interviewing to obtain menstrual history
Procedure: blood sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 1118
Study Start Date: June 1996
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient interviewing + blood sampling

Patients were interviewed at the time of the primary cancer surgery to determine the menstrual history. Blood sampling occurred within 1 day of surgery, and serum samples were shipped frozen to a central laboratory (Mayo Medical Laboratory, Rochester, MN) for E2, Pg, and LH determinations. Serum hormone levels, menstrual cycle length, and day of last menses were used to determine the menstrual phase at which surgery occurred.

Patients were observed every 6 months for the first year postregistration and annually for the next 2 to 10 years postregistration for adjuvant therapy information, disease recurrence, and death.

Behavioral: patient interviewing to obtain menstrual history Procedure: blood sampling

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This trial enrolled premenopausal women age 18 to 55 years who had regular menstrual cycles of 21- to 35-days duration and 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.
Criteria

Inclusion Criteria:

  1. Women age 18 to 55 years
  2. Regular menstrual cycles of 21- to 35-days duration
  3. 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.
  4. 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:

  1. Lactation within the past 3 months
  2. galactorrhea
  3. neoadjuvant therapy
  4. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002762

  Show 54 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
NSABP Foundation Inc
Investigators
Study Chair: Clive S. Grant, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00002762     History of Changes
Other Study ID Numbers: NCCTG-N9431  NCI-2012-02243  NSABP-BI-65  CDR0000064717 
Study First Received: November 1, 1999
Last Updated: July 11, 2016
Health Authority: United States: NCI Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I breast cancer
stage II breast cancer
perioperative/postoperative complications

Additional relevant MeSH terms:
Breast Neoplasms
Postoperative Complications
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 27, 2016