Randomized Trial of Asprin as Adjuvant Therapy for Node-Positive Breast Cancer
National Technical Information Service; 2020.
Non-conventional
in English
| National Technical Information Service | ID: grc-753494
ABSTRACT
In the United States, more than 3 million women are living after a breast cancer diagnosis. There is great need for additional breast cancer adjuvant treatments that are low-cost and low toxicity. These would not only save thousands of lives, but offer improved quality of life for those who do not tolerate current treatments, and treatment options to women in developing countries who currently get none. We will enroll 3000 women with node-positive HER2 negative Stage II or III breast cancer with a 11 randomization to aspirin 325 mg daily versus placebo. Primary endpoint is invasive disease-free survival (including local and distant). Secondary endpoints include recurrence-free interval (local and distant), overall survival, cardiovascular disease, toxicity, and adherence. We will exclude those at high risk of bleeding complications with aspirin (greater than age 70, history of prior stroke, significant gastrointestinal bleeding, anticoagulation) or those with indications for taking aspirin (history of myocardial infarction or atrial fibrillation) Breast cancer advocates will be involved in the creation of all recruitment letters, consent forms, and information sheets. We would conduct the trial in a multi-center collaboration of the Brigham and Womens Hospital, Dana Farber Harvard Cancer Institute, and the Alliance for Clinical Trials in Oncology. The research infrastructure, long-standing leadership roles in clinical trials, and ability to rapidly accrue subjects make the assembled research team ideal to lead a US trial within the proposed time frame.
HEALTH SERVICES; MEDICAL PERSONNEL; THERAPY; CARDIOVASCULAR DISEASES; BIOMEDICAL RESEARCH; BREAST CANCER; CLINICAL TRIALS; COVID-19; GOVERNMENTS; UNITED STATES; DISEASES AND DISORDERS; HEALTH CARE; NEOPLASMS; PATENT APPLICATIONS; CARDIAC ARRHYTHMIAS; DATA ANALYSIS; HISTORY; HUMANITIES; LOCAL GOVERNMENTS; MARYLAND
Full text:
Available
Collection:
Databases of international organizations
Database:
National Technical Information Service
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Year:
2020
Document Type:
Non-conventional
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