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Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion Study to Alliance Study A011502

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
0 Years and older, Female
Study Type
Other
NCT ID
NCT03609021
Protocol IDs
A211601 (primary)
A211601
A211601
NCI-2018-01506
Study Sponsor
Alliance for Clinical Trials in Oncology

Summary

This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A11502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.

Objectives

PRIMARY OBJECTIVES
I. To compare the 1-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative breast cancer enrolled in A011502.

SECONDARY OBJECTIVES
I. To compare the 2-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative breast cancer enrolled in A011502.

CORRELATIVE/EXPLORATORY OBJECTIVES:
I. To evaluate whether baseline mammographic density correlates with baseline markers of inflammation.
II. To evaluate whether changes in mammographic breast density in response to aspirin/placebo therapy from pre-treatment through one and two years of therapy correlate with changes in markers of inflammation over the same time period.

OUTLINE:
Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.

After completion of study, participants are followed up annually until 10 years from registration to study A011502.
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