Breast Cancer Clinical Trial

Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin

Summary

Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).

The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Women must be at increased risk for breast cancer based on any of the following criteria:

Age 30 or older with no prior live birth.
Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
Family history of breast cancer including one first degree or multiple second degree relatives
History of chest radiation before age 30
Multiple prior breast biopsies
Precancerous conditions (DCIS, LCIS, AH)
Prior history of breast or ovarian cancer
Estimated mammographic breast density > 50%
Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml

Exclusion criteria:

Women under 21 or over 45 years old
Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
Women who do not meet risk criteria above
History of hypersensitivity to letrozole or gonadotropin
Uterine and adnexal pathology
Use of clomid or gonadotropin within 30days before the letrozole cycle
Any severe chronic disease of relevance for reproductive function

Study is for people with:

Breast Cancer

Estimated Enrollment:

9

Study ID:

NCT01403688

Recruitment Status:

Completed

Sponsor:

University of Kansas

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There is 1 Location for this study

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The University of Kansas Medical Center
Kansas City Kansas, 66160, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

9

Study ID:

NCT01403688

Recruitment Status:

Completed

Sponsor:


University of Kansas

How clear is this clinincal trial information?

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