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

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Criteria

  • Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and tumor size > 2 cm) and free of recurrence; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility for ER/PR positive tumors; histologic documentation of node positivity is required; bilateral or synchronous breast cancers are allowed as long as both cancers are HER2 negative and at least one of the cancers meets eligibility.
  • If ER and PR negative, tumor must be node positive or >2 cm and node negative. Patients must be registered within 18 months of diagnosis. pN1mic is eligible.
  • If ER and/or PR positive, tumor must be node positive. Patients must be registered within 10 years of diagnosis. pN1mic is eligible.
  • Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed.
  • Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants are encouraged to use acetaminophen for minor pain and fever.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed.
  • No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion, endoscopic or operative intervention.
  • No history of any prior stroke (hemorrhagic or ischemic).
  • No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors.
  • No history of atrial fibrillation or myocardial infarction.
  • No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis).
  • No chronic (duration > 30 days) daily use of oral steroids.  Inhaled or topical steroids are allowed.
  • No known allergy to aspirin.
  • No prior invasive malignancy of any type (including ductal breast carcinoma in situ within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin.  Prior history of in situ carcinoma is allowed.
  • Patients with a prior history of any type of breast cancer greater than 5 years from study screening may participate in this study.
  • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Mohammad Ranginwala, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Paula Gill, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Sandeep Jain, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20308053

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