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Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005079
First Posted: January 27, 2003
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: The timing of breast cancer surgery within the menstrual cycle may affect outcome. It is not yet known if treatment is more effective during the initial or final phase of the menstrual cycle.

PURPOSE: Phase III trial to determine the effect of menstrual cycle phase at surgery in treating premenopausal women who have stage I, stage II, or stage III breast cancer.


Condition Intervention Phase
Breast Cancer Procedure: conventional surgery Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1999
Study Completion Date: October 2004
Detailed Description:

OBJECTIVES:

  • Determine if the timing of breast surgery during the menstrual cycle impacts disease recurrence, progression, or death among different racial groups in premenopausal women with stage I, II, or III breast cancer.
  • Determine if definitive breast cancer surgeries (e.g., lumpectomy or mastectomy) performed during the follicular phase result in poorer prognosis (recurrence, disease progression, or death) compared with surgeries performed during the midcycle or luteal phases in this patient population.

OUTLINE: This is a multicenter study.

Patients undergo either fine needle aspiration concurrently with definitive breast surgery (mastectomy or lumpectomy) or needle-directed excisional biopsy followed by definitive breast surgery.

Patients undergo serum collection for hormonal analysis preoperatively, 24 hours post operatively, at days 7 and 14, and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses.

Patients complete a 30-minute telephone interview regarding medical, family, occupational, and reproductive history and lifestyle habits (e.g., diet, exercise, or environmental exposures). Beginning 24 hours prior to surgery and continuing until the onset of the next menses, patients complete a menstrual cycle journal indicating the start and length of menses.

Patients undergoing mastectomy are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. Patients undergoing adjuvant therapy are followed every 3 months for 3 years and then every 6 months thereafter or every 4 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 2.5 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery

    • Invasive disease (e.g., lobular or ductal)
    • No bilateral disease
  • No distant metastases
  • Premenopausal

    • Regular menses (no amenorrhea of more than 90 days) without hormone replacement
    • Documented last menstrual period
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Premenopausal

Sex:

  • Female

Menopausal status:

  • See Disease Characteristics

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other prior malignancies
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No preoperative chemotherapy

Endocrine therapy:

  • No concurrent hormonal replacement therapy
  • No concurrent interruptive oral contraceptive use of less than 3 months

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  • No prior hysterectomy and/or bilateral oophorectomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005079


Locations
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Helena R. Chang, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00005079     History of Changes
Other Study ID Numbers: UCLA-9810046
CDR0000067686 ( Registry Identifier: PDQ (Physician Data Query) )
UCSD-985772
NCI-G00-1724
First Submitted: April 6, 2000
First Posted: January 27, 2003
Last Update Posted: May 15, 2013
Last Verified: April 2003

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases