A Phase 3 interventional study of Placebo and Aspirin in Node Positive HER2 Negative Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology. Terminated at 1,452 sites in 4 countries. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Treatment
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.
This is a randomized double-blind placebo-controlled phase III trial of aspirin (300 mg daily) in early stage node-positive HER2 negative breast cancer patients. Patients will be randomized 1:1 within stratum defined by: Hormone Receptor status (HR positive vs HR negative), body mass index (\<30 vs ≥ 30 kg/m2) and stage (Stage II vs III).
The primary objective of this trial is to compare the effect of aspirin versus placebo upon invasive disease free survival (iDFS).
Primary objective To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients.
Secondary objectives
To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon:
Patients are followed up to 10 years after study enrollment.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 3,021 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →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.
Counted across the registry records on this site, refreshed daily.
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.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.
Drug: Aspirin
Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Other: Placebo
Given PO
Given PO
Median Invasive Disease-free Survival (iDFS)
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.
Time frame: 5 years
Median Overall Survival (OS)
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.
Time frame: 5 years
Median Distant Disease Free Survival (DDFS)
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.
Time frame: 5 years
Incidence of Cardiovascular Disease (Including Cerebrovascular Events, Myocardial Infarction, or Coronary Artery Disease Requiring Stent Placement, Angioplasty, or Bypass Surgery)
The count of patients with cardiovascular disease by arm.
Time frame: 5 years
Incidence of Toxicities, Graded Using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.3
The count of patients that experianced at least one grade 3 or higher adverse event, regardless of the attribution to study drug.
Time frame: 5 years
| Milestone | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Started | 1511 | 1510 |
| Completed | 1511 | 1510 |
| Not completed | 0 | 0 |
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.
| Months | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Median Invasive Disease-free Survival (iDFS) | NA (NA to NA) | NA (NA to NA) |
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.
| Months | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Median Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
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.
| Months | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Median Distant Disease Free Survival (DDFS) | NA (NA to NA) | NA (NA to NA) |
The count of patients with cardiovascular disease by arm.
| Participants | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Incidence of Cardiovascular Disease (Including Cerebrovascular Events, Myocardial Infarction, or Coronary Artery Disease Requiring Stent Placement, Angioplasty, or Bypass Surgery) | 2 | 2 |
The count of patients that experianced at least one grade 3 or higher adverse event, regardless of the attribution to study drug.
| Participants | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Incidence of Toxicities, Graded Using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.3 | 145 | 131 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Aspirin) | 48/1,511 (3.2%) | 99/1,393 (7.1%) | 621/1,393 (44.6%) |
| Arm II (Placebo) | 43/1,510 (2.8%) | 91/1,415 (6.4%) | 726/1,415 (51.3%) |
| Event | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| Infections and infestations - Oth specInfections and infestations | 7/1393 | 2/1415 |
| BruisingInjury, poisoning and procedural complications | 6/1393 | 6/1415 |
| DyspepsiaGastrointestinal disorders | 3/1393 | 6/1415 |
| Thromboembolic eventVascular disorders | 5/1393 | 6/1415 |
| Surgical and medical proced - Oth specSurgical and medical procedures | 5/1393 | 5/1415 |
| Skin infectionInfections and infestations | 3/1393 | 5/1415 |
| Neoplasms benign, mal, uncpec - Oth specNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/1393 | 5/1415 |
| DepressionPsychiatric disorders | 4/1393 | 2/1415 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 4/1393 | 3/1415 |
| NauseaGastrointestinal disorders | 3/1393 | 4/1415 |
| Event | Arm I (Aspirin) | Arm II (Placebo) |
|---|---|---|
| BruisingInjury, poisoning and procedural complications | 179/1393 | 376/1415 |
| DyspepsiaGastrointestinal disorders | 166/1393 | 168/1415 |
| Hot flashesVascular disorders | 66/1393 | 74/1415 |
| FatigueGeneral disorders and administration site conditions | 62/1393 | 59/1415 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 55/1393 | 58/1415 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 40/1393 | 57/1415 |
| HypertensionVascular disorders | 43/1393 | 50/1415 |
| HeadacheNervous system disorders | 42/1393 | 37/1415 |
| PainGeneral disorders and administration site conditions | 26/1393 | 41/1415 |
| Peripheral sensory neuropathyNervous system disorders | 35/1393 | 41/1415 |
| Age, Continuous(years) | Arm I (Aspirin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Median | 53 (23 to 69) | 52 (25 to 69) | 53 (23 to 69) |
| Sex: Female, Male(Participants) | Arm I (Aspirin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Female | 1502 | 1503 | 3005 |
| Male | 9 | 7 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Aspirin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 112 | 113 | 225 |
| Not Hispanic or Latino | 1368 | 1351 | 2719 |
| Unknown or Not Reported | 31 | 46 | 77 |
| Race (NIH/OMB)(Participants) | Arm I (Aspirin) | Arm II (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 8 | 17 | 25 |
| Asian | 66 | 55 | 121 |
| Native Hawaiian or Other Pacific Islander | 6 | 7 | 13 |
| Black or African American | 140 | 139 | 279 |
| White | 1240 | 1231 | 2471 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 51 | 61 | 112 |
Showing the first 100 of 1,452 sites across 4 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Data sharing details ↗ · nctn-data-archive.nci.nih.gov
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
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