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 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

October 13, 2009

Start Date ^ICMJE

June 1996

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Brief Summary

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.

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Breast Cancer
Perioperative/Postoperative Complications

Intervention ^ICMJE

Other: questionnaire administration
Procedure: conventional surgery

Study Arms / Comparison Groups

Publications *

Grant CS, Ingle JN, Suman VJ, Dumesic DA, Wickerham DL, Gelber RD, Flynn PJ, Weir LM, Intra M, Jones WO, Perez EA, Hartmann LC. Menstrual Cycle and Surgical Treatment of Breast Cancer: Findings From the NCCTG N9431 Study. J Clin Oncol. 2009 Jun 1; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1100

Completion Date

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00002762

Responsible Party

Study ID Numbers ^ICMJE

CDR0000064717, NCCTG-N9431, NSABP-BI-65

Study Sponsor ^ICMJE

North Central Cancer Treatment Group

Collaborators ^ICMJE

National Cancer Institute (NCI)
National Surgical Adjuvant Breast and Bowel Project (NSABP)

Investigators ^ICMJE

Study Chair:	Clive S. Grant, MD	Mayo Clinic
Study Chair:	D. Lawrence Wickerham, MD	Allegheny Cancer Center at Allegheny General Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP