Randomized Trial of Asprin as Adjuvant Therapy for Node-Positive Breast Cancer
Abstract
We propose to test whether aspirin helps women with breast cancer live longer. We will do this with a randomized trial, an experiment where half the women are randomly assigned to receive aspirin and half randomly assigned receive a placebo (dummy) pill. If aspirin works, within 5 years we would have a cost-effective breast cancer therapy that would benefit the entire world, and particularly developing nations. Aspirin has been widely tested in clinical trials of other diseases (to prevent heart disease and colon cancer) and is available over the counter. Although aspirin has some known risks, most notably bleeding, it has been safely used in many trials and has clearly been shown to be helpful among certain populations to prevent heart disease. In the United States, more than three million women are living after a breast cancer diagnosis. Although chemo- and hormonal therapies have helped women with breast cancer live longer, they are expensive and have many side effects. Also, women whose tumors are not sensitive to hormones have limited treatment options. Compelling laboratory science and experiments in animals hint that aspirin may prevent recurrence and death among breast cancer survivors. Also, studies where scientists observe people s behavior, and correlate that behavior with their health, also support the promise of aspirin. Two of the investigators of this proposal, Drs. Michelle Holmes and Wendy Chen, have reported results from one such study, the Nurses Health Study. They reported that breast cancer survivors who were regular aspirin users had a 50% lower risk of breast cancer recurrence and death compared to those who did not use aspirin. This has led to intense interest among physicians and survivors to explore the therapeutic benefits of aspirin. Of five other similar published studies, three showed a similar marked survival benefit. Results from observational studies such as these can be confounded by the fact that aspirin use may be correlated with other healthy behaviors leading to improved survival. Randomized trials, where experimenters assign patients to either aspirin or a placebo pill cannot be confounded by healthy behaviors as the patients do not know which pill they are getting. That is why a 2012 British study that analyzed several randomized trials of aspirin used to prevent heart disease to see whether the aspirin incidentally affected cancer risk was an important tipping point in this question. That study found that people assigned to take aspirin to prevent heart disease had a 50% reduced risk of metastatic cancer. As metastatic cancer almost always leads to death from that cancer, this result is similar to the 50% lower risk of breast cancer death among aspirin users seen in four of the six observational studies and strengthens the case for aspirin s survival benefit. However, the novel and promising theory that aspirin could reduce recurrence and death among breast cancer survivors can only be addressed definitively through a randomized trial among breast cancer survivors. The Department of Defense Breast Cancer Research Program Breakthrough Award is a unique mechanism for the support of such a study, which is not a good fit for traditional funding mechanisms. Research on cancer treatments is usually supported by the pharmaceutical industry. Aspirin is generic and widely available and hence there is little industry incentive to support such a study. Regardless of whether aspirin prevents breast cancer recurrence, our study will create a valuable biospecimen bank with tumor, genetics, plasma, urine, and lifestyle factors collected for all participants, which will create an invaluable resource for breast cancer researchers. If proven effective, adding aspirin to current chemo- and hormonal therapy may enhance survival. There are also circumstances in which aspirin may be a more adhered-to alternative. For instance, about 50% of American women with hormone-re
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 29, 2016
- Source ID
- W81XWH1510268
Entities
People
- Eric Winer
Organizations
- Dana–Farber Cancer Institute
- United States Army