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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2022
  • participants needed
    384
  • sponsor
    Alliance for Clinical Trials in Oncology
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Updated on 15 January 2021
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Investigator
Marie Wood, MD
Primary Contact
Northwest Hospital Center (3.8 mi away) Contact
+492 other location
aspirin
cancer
breast surgery
breast cancer
endocrine therapy
hormone therapy
tamoxifen
aromatase inhibitor
mammogram
breast imaging reporting and data system

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.

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 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.

Details
Treatment biospecimen collection, Screening Mammography, Screening Mammography
Clinical Study IdentifierNCT03609021
SponsorAlliance for Clinical Trials in Oncology
Last Modified on15 January 2021

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Eligibility

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Inclusion Criteria

Are you female?
Do you have any of these conditions: Ductal Carcinoma In Situ (DCIS) or Breast Cancer or Ductal Carcinoma In Situ or Estrogen Receptor Negative or Progesterone Receptor Negative?
Do you have any of these conditions: Breast Cancer or Estrogen Receptor Negative or breast carcinoma or Ductal Carcinoma In Situ or Progesterone Receptor Negative or Ductal Carcinoma In S...?
Do you have any of these conditions: Progesterone Receptor Negative or Estrogen Receptor Negative or Breast Cancer Diagnosis or Ductal Carcinoma In Situ or Ductal Carcinoma In Situ (DCIS)...?
Do you have any of these conditions: Progesterone Receptor Negative or Ductal Carcinoma In Situ or Breast Cancer or Ductal Carcinoma In Situ (DCIS) or breast carcinoma or Breast Cancer Di...?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or Estrogen Receptor Negative or Progesterone Receptor Negative or Ductal Carcinoma In Situ or Ductal Carcino...?
Do you have any of these conditions: Estrogen Receptor Negative or Breast Cancer or Ductal Carcinoma In Situ (DCIS) or Ductal Carcinoma In Situ or breast carcinoma or Breast Cancer Diagno...?
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
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