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Alliance A011502

Aspirin for Breast Cancer Study (ABC Study)

Status:

Recruiting | Phase III 

Official Title: 

A Randomized Phase III Double-Blinded Placebo-Controlled Trial of Aspirin as Adjuvant Therapy for Her2 Negative Breast Cancer.

Study Purpose: 

To compare the good and bad effects of using aspirin after completing the usual chemotherapy, surgery, and/or radiation therapy for breast cancer.

Interventions:    

  • Aspirin/Placebo 
  • Optional Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: Aspirin 300 mg oral pill daily x 5 years
  • ARM II: Placebo oral pill daily x 5 years

After completion of study therapy, patients are followed up every year for 10 years from study start.

Key Participation Requirements

Gender: 

Male or Female

Age: 

19 to 69 years of age

Diagnosis: 

Stage II or III breast cancer

Marker Status: 

Her2 negative, all ER/PR statuses are accepted

Prior Therapy: 

Surgery and chemotherapy (before or after surgery). May or may not have had radiation. If appropriate, patients are allowed to be on hormone therapy at the same time as the study medication.

Must be registered to the study within 12 months of diagnosis.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Alliance A011502

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!