Evaluation of Mammographic Breast Density in Participants with Hormone Receptor-Negative Breast C… (NCT03609021) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Mammographic Breast Density in Participants with Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502
Stopped: A211601 closed prematurely due to slow accrual.
United States18 participantsStarted 2019-02-26
Plain-language 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.
Who can participate
SexFEMALE
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Inclusion Criteria:
* Must be either concurrently enrolling or previously enrolled to Alliance A011502. Eligible patients may be either pre- or post-menopausal.
* Patients must have either hormone receptor-negative breast cancer or be ER+ patients who have completed hormone therapy (e.g., tamoxifen, aromatase inhibitors) at least 6 months prior to registration to A011502.
* 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 prior to registration must be available for submission.
* For patients enrolling concurrently with Alliance A011502: Baseline digital screening mammogram must be taken within 8 weeks prior to registration to A211601. If a baseline mammogram within 8 weeks is not available, a new screening mammogram must be performed prior to treatment on Alliance A011502
* For patients enrolling retrospectively: The patient's previous routine mammogram on file must be within 1 year prior to registration to A011502.
* 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 el…
What they're measuring
1
Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms