Last updated on August 2019

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy Surgery and/or Radiation Therapy


Brief description of study

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) 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.

Detailed Study Description

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

  1. To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon:
  2. Distant disease-free survival
  3. Overall survival
  4. Cardiovascular disease (see Section11.3)
  5. To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients.
  6. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients.
  7. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers.
  8. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation for whom there is greater benefit of aspirin versus placebo upon iDFS.

Patients are followed up to 10 years after study enrollment.

Clinical Study Identifier: NCT02927249

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Pompton, NJ United States
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Overlook Hospital

Summit, NJ United States
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Community Medical Center

Toms River, NJ United States
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Virtua Voorhees

Voorhees, NJ United States
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Jacobi Hospital

Bronx, NY United States
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Kings County Hospital

Brooklyn, NY United States
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Elmhurst Hospital Center

Elmhurst, NY United States
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Glens Falls Hospital

Glens Falls, NY United States
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Queens Hospital Center

Jamaica, NY United States
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Orange Regional Medical Center

Middletown, NY United States
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NYU Winthrop Hospital

Mineola, NY United States
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Mount Sinai Union Square

New York, NY United States
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Mount Sinai West

New York, NY United States
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Nyack Hospital

Nyack, NY United States
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University of Rochester

Rochester, NY United States
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Staten Island University Hospital

Staten Island, NY United States
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Wayne Memorial Hospital

Goldsboro, NC United States
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Cone Health Cancer Center

Greensboro, NC United States
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AdventHealth Hendersonville

Hendersonville, NC United States
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Maria Parham Hospital

Henderson, NC United States
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Onslow Memorial Hospital

Jacksonville, NC United States
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Rex Cancer Center

Raleigh, NC United States
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Duke Raleigh Hospital

Raleigh, NC United States
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Annie Penn Memorial Hospital

Reidsville, NC United States
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Rowan Regional Medical Center

Salisbury, NC United States
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Johnston Memorial Hospital

Smithfield, NC United States
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Novant Health Forsyth Medical Center

Winston-Salem, NC United States
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Novant Health Oncology Specialists

Winston-Salem, NC United States
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Winston-Salem Health Care

Winston-Salem, NC United States
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Altru Cancer Center

Grand Forks, ND United States
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Alliance Cancer Center

Alliance, OH United States
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Summa Barberton Hospital

Barberton, OH United States
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Indu and Raj Soin Medical Center

Beavercreek, OH United States
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Mercy Medical Center

Canton, OH United States
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Aultman Health Foundation

Canton, OH United States
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Miami Valley Hospital South

Centerville, OH United States
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Bethesda North Hospital

Cincinnati, OH United States
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Mount Carmel East Hospital

Columbus, OH United States
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Riverside Methodist Hospital

Columbus, OH United States
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Grant Medical Center

Columbus, OH United States
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Doctors Hospital

Columbus, OH United States
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Miami Valley Hospital

Dayton, OH United States
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Delaware Radiation Oncology

Delaware, OH United States
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Grady Memorial Hospital

Delaware, OH United States
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Armes Family Cancer Center

Findlay, OH United States
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Blanchard Valley Hospital

Findlay, OH United States
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