An observational study in Breast Carcinoma, Estrogen Receptor Negative and Progesterone Receptor Negative, sponsored by Alliance for Clinical Trials in Oncology. Terminated at 515 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Alliance for Clinical Trials in Oncology · Observational
Among 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology — 5 open to participants now, 15 under way, 12 of them phase 3. Breast Neoplasms · Alliance for Clinical Trials in Oncology.
Among the 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology, this one is the 18th largest by enrollment of the 18 observational ones, is one of 3 that started in 2019, is one of 12 observational ones, and was the 83rd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 18 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →5 of the 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology are open now, in 3 countries. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →96 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 3 started in 2019.
Median enrollment 201 across the 77 interventional studies, 530 across the 18 observational. Of the 77 that completed or were terminated, 29 (38%) have results posted.
Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
5 of the studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01953588Phase 3Alliance for Clinical Trials in OncologyFulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery | 2027-04-01 |
| NCT04711109Phase 3Alliance for Clinical Trials in OncologyStudying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation | 2027-07 |
| NCT05751668Alliance for Clinical Trials in OncologyFinding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel | 2026-11-15 |
| NCT05334069Alliance for Clinical Trials in OncologyCollecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection | 2027-01-31 |
| NCT07059884Alliance for Clinical Trials in OncologyDistance-Based Exercise to Preserve Function and Prevent Disability | 2027-07-01 |
Among the 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology, from their registry updates:
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 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.
Participants with hormone receptor negative or positive breast cancer enrolled in Alliance A011502.
Inclusion Criteria:
Patients must have baseline breast density measurement as defined by one of the following:
Baseline digital screening mammogram (mediolateral [MLO] and craniocaudal [CC] views) taken prior to registration must be available for submission.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: Biospecimen Collection
Provide bilateral mammogram
Undergo collection of blood sample
Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms
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.
Time frame: At 1 year post-registration to A011502
Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms
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.
Time frame: At 2 years post-registration to A011502
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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