Completed

Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

conventional surgery

Procedure
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 1999
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: May 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00005079
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: May 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Rebecca and John Moores UCSD Cancer Center

La Jolla, United StatesOpen Rebecca and John Moores UCSD Cancer Center in Google Maps

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United States
Completed2 Study Centers