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

Stopped early

Conditions studied: Breast Carcinoma, Estrogen Receptor Negative, Progesterone Receptor Negative

In brief

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.

Key facts

Study ID

NCT03609021

Run by

Alliance for Clinical Trials in Oncology

People needed

18

Starts

2019-02-26

Expected to finish

2022-07-18

Last updated by the study team

2025-01-16

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 eligible.
• Not pregnant and not nursing.

Where it is running

• Arizona Breast Cancer Specialists-Gilbert — Gilbert, Arizona, United States
• Virginia G Piper Cancer Care-Glendale — Glendale, Arizona, United States
• Kingman Regional Medical Center — Kingman, Arizona, United States
• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States
• Arizona Breast Cancer Specialists-Phoenix — Phoenix, Arizona, United States
• Arizona Breast Cancer Specialists — Scottsdale, Arizona, United States
• Arizona Breast Cancer Specialists-Scottsdale — Scottsdale, Arizona, United States
• Virginia G Piper Cancer Care-Del Camino — Scottsdale, Arizona, United States
• Arizona Center for Cancer Care-Surprise — Surprise, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Kaiser Permanente West Los Angeles — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Kaiser Permanente-Ontario — Ontario, California, United States
• Kaiser Permanente - Panorama City — Panorama City, California, United States
• Kaiser Permanente-Riverside — Riverside, California, United States
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States

Full record on ClinicalTrials.gov

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