Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
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.
Age
18–69
Sex
ALL
Healthy volunteers
Not accepted
