E-Newsletter - November 2015

Alliance Researchers to Explore Use of Aspirin to Treat
Breast Cancer

Alliance researchers have recently been awarded a $10 million Breakthrough Award by the United States Department of Defense's Office of the Congressionally Directed Medical Research Program to test whether aspirin helps women with breast cancer avoid recurrence and live longer. This is the first ever randomized trial in the U.S. testing aspirin in the disease, which impacts more than 3 million American women who are living with a breast cancer diagnosis.

The Aspirin for Breast Cancer (ABC) Trial will recruit 3,000 women with Stages II and III breast cancer through the Alliance. Half of the women participating in the trial will be randomly assigned to receive aspirin and half to receive a placebo pill. Previous observational research, where scientists observe peoples' behavior, and correlate that behavior with their health, has found that breast cancer survivors who were regular aspirin users had a 50 percent lower risk of breast cancer recurrence and death compared to those who did not use aspirin.  This, along with other promising preclinical research, has led to intense interest among physicians and survivors to explore the therapeutic benefits of aspirin.

"The epidemiological and preclinical evidence* linking aspirin with a positive effect on breast cancer recurrence is very strong, but we need a prospective trial like this one to definitively determine the role of aspirin in the disease," said Michelle Holmes, MD, DrPH, Associate Professor of Medicine and Epidemiology in the Channing Division of Network Medicine at Brigham and Women’s Hospital and Partnering Principal Investigator of the trial.

If proven effective, adding aspirin to current chemo- and hormonal therapy may enhance survival.  Outside the U.S., aspirin's low cost ($6/year) would make it a major aid in developing nations unable to access expensive therapies.  

"Although chemo- and hormonal therapies have helped women with breast cancer live longer, they are expensive and have many side effects," said Wendy Chen, MD, MPH, Senior Physician at the Susan F. Smith Center for Women's Cancers at Dana-Farber and Co-Principal Investigator. "Women whose tumors are not sensitive to hormones have limited treatment options. The results of this trial, if positive, could have a huge impact on the disease, as we have estimated that that aspirin may save 10,000 lives a year in the U.S. and 75,000 lives in low-income countries."

The Breakthrough Award, which is a unique mechanism for the support of studies that are not a good fit for traditional funding mechanisms, requires involvement of patient advocates at all levels of the research review and performance since they play an important role in education around breast cancer prevention and treatment, and often have personal experience with the disease.   

"This trial will be the first of its kind in United States," said Eric Winer, MD, Director of Breast Oncology Program, Professor of Medicine, and Thompson Chair of Breast Cancer Research at Dana-Farber Cancer Institute. "The potential benefits of aspirin in preventing breast recurrence are significant and we look forward to determining if aspirin could augment current therapies.  This is a treatment that needs to be evaluated further." Dr. Winer is also a Partnering Principal Investigator of the grant.

The investigators plan to combine results with a large-scale international trial that is also exploring the role of aspirin in cancer and will allow researchers to analyze whether aspirin's benefit is specific to certain subtypes of breast cancer. Researchers note that although aspirin has some known risks, most notably bleeding, it has been widely and safely used in many trials and in clinical practice to prevent other diseases, such as heart disease and colon cancer.   

*Supporting research and publications:

  1. Aspirin intake and survival after breast cancer
    Journal of Clinical Oncology, Mar 20, 2010
  2. Effect of daily aspirin on risk of cancer metastasis: a study of incident cancers during randomised controlled trials.
    Lancet, Apr 28, 2012
  3. Add-Aspirin Trial, http://www.addaspirintrial.org/
  4. A Cancer Treatment in Your Medicine Cabinet?
    The New York Times, May 19, 2014


*  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *

For other articles in the November issue of the Alliance E-News newsletter, see below.