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

• ClinicalTrials.gov Identifier: NCT03609021
• Recruitment Status: Recruiting
• First Posted: August 1, 2018
• Last Update Posted: November 20, 2019
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Tracking Information

• First Submitted Date: July 25, 2018
• First Posted Date: August 1, 2018
• Last Update Posted Date: November 20, 2019
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2018)

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.

Original Primary Outcome Measures (submitted: July 25, 2018)

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 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.

• Change History: Complete list of historical versions of study NCT03609021 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 1, 2018)

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.

Original Secondary Outcome Measures (submitted: July 25, 2018)

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 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

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 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood

• Sampling Method: Non-Probability Sample
• Study Population: Participants with hormone receptor-negative breast cancer concurrently enrolling to Alliance A011502

Condition

• Breast Carcinoma
• Estrogen Receptor Negative
• Progesterone Receptor Negative

Intervention

• Procedure: Screening Mammography
  Provide bilateral mammogram
• Procedure: Biospecimen Collection
  Undergo collection of blood sample

Study Groups/Cohorts

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.

Interventions:

• Procedure: Screening Mammography
• Procedure: Biospecimen Collection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 25, 2018): 384
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2022
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03609021
• Other Study ID Numbers: A211601; NCI-2018-01506 ( Registry Identifier: NCI Clinical Trial Reporting Program ); UG1CA189823 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Alliance for Clinical Trials in Oncology
• Study Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Marie Wood, MD; University of Vermont

• PRS Account: Alliance for Clinical Trials in Oncology
• Verification Date: November 2019