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Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

Breast Carcinoma Clinical Trial

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

Clinical Trial Summary

This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. 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.

Clinical Trial Description

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 or positive 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 or positive breast cancer enrolled in A011502. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03609021
Study type Observational
Source Alliance for Clinical Trials in Oncology
Contact
Status Terminated
Phase
Start date August 1, 2018
Completion date July 18, 2022
View Details
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