Trial · NCT02927249
Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
NCT02927249, Phase 3, Terminated, Alliance for Clinical Trials in Oncology; results first posted 2023-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy. Trials, record NCT02927249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02927249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
- NCT number
- NCT02927249
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,021 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Node Positive HER2 Negative Breast Cancer
- Interventions
- Placebo, Aspirin
- First posted
- 2016-10-07
- Last updated
- 2026-09-04
- Results first posted
- 2023-03-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Invasive Disease-free Survival (iDFS) | 5 years | Invasive disease-free survival (iDFS), is defined as time from randomization to the first occurrence of any one of the following events for invasive disease: Distant recurrence, locoregional recurrence, ipsilateral or contralateral breast cancer, second primary (non-breast) invasive cancer or death from any cause. Censoring will occur on the date the patient was last known to be alive and free from all invasive breast cancer and second invasive primaries. |
| Secondary | Median Overall Survival (OS) | 5 years | Overall survival (OS) is defined as the time from randomization to death from any cause; surviving patients will be censored at the date last known to be alive. |
| Secondary | Median Distant Disease Free Survival (DDFS) | 5 years | DDFS is defined as the time from randomization to the first occurrence of any one of the following events for invasive disease: Distant recurrence, second primary (non-breast) invasive cancer or death from any cause; censoring will occur at the date the patient was last known to be alive and free from distant invasive breast cancer and second invasive primaries. |
| Secondary | Incidence of Cardiovascular Disease (Including Cerebrovascular Events, Myocardial Infarction, or Coronary Artery Disease Requiring Stent Placement, Angioplasty, or Bypass Surgery) | 5 years | The count of patients with cardiovascular disease by arm. |
| Secondary | Incidence of Toxicities, Graded Using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.3 | 5 years | The count of patients that experianced at least one grade 3 or higher adverse event, regardless of the attribution to study drug. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Invasive Disease-free Survival (iDFS) | 5 years | Months | MEDIAN | |
| SECONDARY | Median Overall Survival (OS) | 5 years | Months | MEDIAN | |
| SECONDARY | Median Distant Disease Free Survival (DDFS) | 5 years | Months | MEDIAN | |
| SECONDARY | Incidence of Cardiovascular Disease (Including Cerebrovascular Events, Myocardial Infarction, or Coronary Artery Disease Requiring Stent Placement, Angioplasty, or Bypass Surgery) | Up to 5 years | |||
| SECONDARY | Incidence of Toxicities, Graded Using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.3 | Up to 5 years |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Invasive Disease-free Survival (iDFS) | Arm I (Aspirin) | NA | 95% Confidence Interval NA to NA | Months | |
| Median Invasive Disease-free Survival (iDFS) | Arm II (Placebo) | NA | 95% Confidence Interval NA to NA | Months | |
| Median Overall Survival (OS) | Arm I (Aspirin) | NA | 95% Confidence Interval NA to NA | Months | |
| Median Overall Survival (OS) | Arm II (Placebo) | NA | 95% Confidence Interval NA to NA | Months | |
| Median Distant Disease Free Survival (DDFS) | Arm I (Aspirin) | NA | 95% Confidence Interval NA to NA | Months | |
| Median Distant Disease Free Survival (DDFS) | Arm II (Placebo) | NA | 95% Confidence Interval NA to NA | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Aspirin) | 1,511 | |
| Overall Study | STARTED | Arm II (Placebo) | 1,510 | |
| Overall Study | COMPLETED | Arm I (Aspirin) | 1,511 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 1,510 | |
| Overall Study | NOT COMPLETED | Arm I (Aspirin) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 0 |
Source ClinicalTrials.gov
Adverse events780
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Aspirin) | 13 | 1,393 | 16 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Placebo) | 9 | 1,415 | 11 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm I (Aspirin) | 4 | 1,393 | 5 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm II (Placebo) | 6 | 1,415 | 8 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Aspirin) | 0 | 1,393 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Placebo) | 1 | 1,415 | 1 |
| other | Lymph node pain | Blood and lymphatic system disorders | Arm I (Aspirin) | 0 | 1,393 | 0 |
| other | Lymph node pain | Blood and lymphatic system disorders | Arm II (Placebo) | 2 | 1,415 | 2 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm I (Aspirin) | 1 | 1,393 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm II (Placebo) | 0 | 1,415 | 0 |
1 to 10 of 780Source ClinicalTrials.gov
See all 780 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Aspirin) | 48 | 1,511 |
| Total, all-cause mortality | Arm II (Placebo) | 43 | 1,510 |
| Total, other adverse events | Arm I (Aspirin) | 621 | 1,393 |
| Total, other adverse events | Arm II (Placebo) | 726 | 1,415 |
| Total, serious adverse events | Arm I (Aspirin) | 99 | 1,393 |
| Total, serious adverse events | Arm II (Placebo) | 91 | 1,415 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Aspirin) vs Arm II (Placebo): deaths from any cause | Trial comparisons |
| Arm I (Aspirin) vs Arm II (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02927249
GET https://conductscience.org/api/trials/v1/NCT02927249/events?page=2