Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
- Conditions
- Node Positive HER2 Negative Breast Cancer
- Interventions
- Other: Placebo
- Registration Number
- NCT02927249
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3021
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II (Placebo) Placebo Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity. Arm I (aspirin) Aspirin Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Median Invasive Disease-free Survival (iDFS) 5 years 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.
- Secondary Outcome Measures
Name Time Method Median Overall Survival (OS) 5 years 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.
Median Distant Disease Free Survival (DDFS) 5 years 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.
Incidence of Toxicities, Graded Using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.3 Up to 5 years Incidence of Cardiovascular Disease (Including Cerebrovascular Events, Myocardial Infarction, or Coronary Artery Disease Requiring Stent Placement, Angioplasty, or Bypass Surgery) Up to 5 years
Trial Locations
- Locations (1445)
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Southern Cancer Center PC-Daphne
🇺🇸Daphne, Alabama, United States
Southern Cancer Center PC-Mobile
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Providence
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Springhill
🇺🇸Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Scroll for more (1435 remaining)University of Alabama at Birmingham Cancer Center🇺🇸Birmingham, Alabama, United States