Accession Number : AD1050789


Title :   Randomized Trial of Asprin as Adjuvant Therapy for Node-Positive Breast Cancer


Descriptive Note : Technical Report,15 Sep 2016,14 Sep 2017


Corporate Author : Dana-Farber Cancer Institute Boston United States


Personal Author(s) : Winer, Eric ; Chen,Wendy


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/1050789.pdf


Report Date : 01 Oct 2017


Pagination or Media Count : 16


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 1:1 randomization to aspirin 300 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 (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.


Descriptors :   breast cancer , clinical trials , aspirin , toxicity , epidemiology


Subject Categories : Medicine and Medical Research
      Pharmacology


Distribution Statement : APPROVED FOR PUBLIC RELEASE