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Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Study of Manual Nipple Fluid Aspiration IN Post-Menopausal Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00291083
Enrollment
229
Registered
2006-02-13
Start date
2005-10-31
Completion date
2008-06-30
Last updated
2012-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

NAF, nipple aspirate fluid, breast atypia, high risk for breast cancer, breast epithelial hyperplasia, Ki-67, hormones plus chemoprevention, chemoprevention

Brief summary

To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

Detailed description

To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Interventions

None listed

Sponsors

Carol Fabian, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* women with high a high risk of breast cancer * Older than 18

Exclusion criteria

* anticoagulants * marked breast tenderness * pregnant or within twelve months of breast feeding/childbirth

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026