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NCT03609021 · ClinicalTrials.gov registry record
Evaluation of Mammographic Breast Density in Participants with Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502
A clinical trial, sponsored by Alliance for Clinical Trials in Oncology.
- Terminated
- Registry status
- 18
- Enrollment target
NCT03609021: Clinical Trial study, sponsored by Alliance for Clinical Trials in Oncology.
NCT03609021 is a clinical trial that was terminated before completion, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03609021 was terminated before completion, sponsored by Alliance for Clinical Trials in Oncology.
- TERMINATED
- Registry status
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Screening Mammography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2022-07-18 |
Why NCT03609021 stopped before completion
NCT03609021 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT03609021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03609021 about?
NCT03609021 is a clinical study titled "Evaluation of Mammographic Breast Density in Participants with Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502". 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...
What is the current status of trial NCT03609021?
This trial is currently terminated. The enrollment target is 18 participants. The study started on 2019-02-26. Estimated completion is 2022-07-18.
What interventions are being tested in trial NCT03609021?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Screening Mammography (PROCEDURE).
Who is sponsoring clinical trial NCT03609021?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
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