NCT02927249

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

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,021 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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: 1. Distant disease-free survival 2. Overall survival 3. Cardiovascular disease (see Section11.3) 2. To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients. 3. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients. 4. 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. 5. 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.

Conditions

• Node Positive HER2 Negative Breast Cancer

Interventions

Type	Name	Description
OTHER	Placebo	Given PO
DRUG	Aspirin	Given PO

Timeline

• Start date: 2016-12-08
• Primary completion: 2021-12-13
• Completion: 2023-02-15
• First posted: 2016-10-07
• Last updated: 2023-04-05
• Results posted: 2023-03-27

Locations

1,452 sites across 4 countries: United States, Canada, Guam, Puerto Rico