NCT03609021

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Carcinoma
• Estrogen Receptor Negative
• Progesterone Receptor Negative

Interventions

Type	Name	Description
PROCEDURE	Screening Mammography	Provide bilateral mammogram
PROCEDURE	Biospecimen Collection	Undergo collection of blood sample

Timeline

• Start date: 2019-02-26
• Primary completion: 2022-07-15
• Completion: 2022-07-18
• First posted: 2018-08-01
• Last updated: 2025-01-16

Locations

515 sites across 2 countries: United States, Guam