The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
18 Years
64 Years
Female
Breast Cancer
Trial Information
The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
OBJECTIVES:
Primary
- Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of
healthy women at moderate to high risk of developing breast cancer, defined by family
history or prior atypical biopsy.
Secondary
- Correlate cellular atypia with breast cancer, biochemical tumor markers, growth
factors, and genetic and protein markers in these participants.
- Determine cancer risk and incidence utilizing these methods of screening in these
participants.
- Observe the natural history of atypia in these participants over a total of 10 years.
- Determine whether these techniques may serve as supplementary tools in future screening
of these participants.
OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months
for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for
4.5 years.
Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage
and endoscopy.
Participants are followed annually for a total of 10 years.
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within
approximately 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Significant family history or prior atypical biopsy indicative of a moderate or high
risk of developing breast cancer
- No concurrent inflammatory breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 to 64
Sex
- Female
Menopausal Status
- Premenopausal or postmenopausal
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No prior allergy to EMLA cream or lidocaine
- No severe illness that would preclude study participation
- No mental illness or handicap that would preclude study compliance
- No concurrent active infection or inflammation in the breast being studied
- Not unconscious
- Not pregnant
- No nursing within the past 12 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may
disrupt the ductal systems within 2 cm of the nipple
- No prior breast implantation on proposed lavage side
Type of Study:
Interventional
Study Design:
Primary Purpose: Screening
Principal Investigator
Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000358797
NCT ID:
NCT00081003
Start Date:
November 2003
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
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