Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed Premenopausal NCI UCLA-9810046 UCSD-985772, NCI-G00-1724, NCT00005079

Objectives

1. 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.
2. 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.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Helena Chang, MD, PhD, Protocol chair		Ph: 310-794-5640; 888-798-0719 Email: hchang@mednet.ucla.edu

Registry Information
Official Title		Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis
Trial Start Date		1999-01-21
Registered in ClinicalTrials.gov		NCT00005079
Date Submitted to PDQ		2000-02-23
Information Last Verified		2003-04-23
NCI Grant/Contract Number		P30-CA16042

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