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Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Helena R. Chang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

UCLA-9810046

NCT ID:

NCT00005079

Start Date:

January 1999

Completion Date:

October 2004

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658