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Trial record 1 of 1 for:    A211601
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Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

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ClinicalTrials.gov Identifier: NCT03609021
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Breast Carcinoma Estrogen Receptor Negative Progesterone Receptor Negative Procedure: Screening Mammography Procedure: Biospecimen Collection

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 384 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion Study to Alliance Study A011502
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (bilateral screening mammogram)
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.
 Procedure: Screening Mammography
Provide bilateral mammogram

Procedure: Biospecimen Collection
Undergo collection of blood sample


Outcome Measures
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Primary Outcome Measures :
  1. Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 1 year post-registration to A011502 ]
    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. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline.


Secondary Outcome Measures :
  1. Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 2 years post-registration to A011502 ]
    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 compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with hormone receptor negative or positive breast cancer enrolled in Alliance 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609021


Contacts
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Contact: Marie Wood, MD 802-656-5452 marie.wood@uvm.edu

Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Marie Wood, MD University of Vermont
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03609021    
Other Study ID Numbers: A211601
NCI-2018-01506 ( Registry Identifier: NCI Clinical Trial Reporting Program )
UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases