Kingman, Arizona 86401

  • Progesterone Receptor Negative

Purpose:

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.


Study summary:

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.


Criteria:

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 eligible. - Not pregnant and not nursing.


Study is Available At:


Original ID:

A211601


NCT ID:

NCT03609021


Secondary ID:

NCI-2018-01506


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

A211601 closed prematurely due to slow accru


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marie Wood, MD
Study Chair
University of Vermont

Study Dates

Start Date:August 1, 2018
Completion Date:July 18, 2022
Completion Type:Actual
Primary Completion Date:July 15, 2022
Primary Completion Type:Actual
Verification Date:July 2022
Last Changed Date:July 19, 2022
First Received Date:July 25, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms
Time Frame:At 1 year post-registration to A011502
Safety Issues:False
Description:The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms
Outcome Type:Secondary Outcome
Measure:Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms
Time Frame:At 2 years post-registration to A011502
Safety Issues:False
Description:The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) >= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to co

Study Interventions

Intervention Type:Procedure
Name:Screening Mammography
Description:Provide bilateral mammogram
Arm Name:Observational (bilateral screening mammogram)
Intervention Type:Procedure
Name:Biospecimen Collection
Description:Undergo collection of blood sample
Arm Name:Observational (bilateral screening mammogram)

Study Arms

Study Arm Type:Other
Arm Name:Observational (bilateral screening mammogram)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood
Study Population: Participants with hormone receptor negative or positive breast cancer enrolled in Alliance A011502.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 01, 2023

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.