Summary

for females (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Details

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.

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.

Keywords

Breast Carcinoma Estrogen Receptor Negative Progesterone Receptor Negative Breast Neoplasms Screening Mammography Biospecimen Collection

Eligibility

For females

Inclusion Criteria:

  • Must be concurrently enrolling to Alliance A011502. Eligible patients may be either pre- or post-menopausal.
  • Patients must have hormone receptor-negative breast cancer.
  • Patients must have baseline breast density measurement as defined by one of the following:
  • >= 25% breast density, or
  • Scattered areas of fibroglandular density, or
  • Breast composition category b, c, or d, per Breast Imaging Reporting and Data System (BI-RADS) 2013.
  • Baseline digital screening mammogram (mediolateral [MLO] and craniocaudal [CC] views) taken within 8 weeks prior to registration must be available for submission.
  • If baseline mammogram within 8 weeks is not available, a new screening mammogram must be performed prior to treatment on Alliance A011502. To receive reimbursement for the cost of this additional mammogram, institutions may submit the A211601 Reimbursement Form, which is available on the Alliance and Cancer Trials Support Unit (CTSU) web pages.
  • Patients receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible.
  • Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study). Patients with a prior biopsy on the unaffected breast are eligible.
  • Not pregnant and not nursing.

Locations

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Fremont - Rideout Cancer Center accepting new patients
    Marysville California 95901 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
Links
Sign up for this study
ID
NCT03609021
Study Type
Observational
Last Updated