Last updated: Sep 15, 2008
medical-study
Clinical trials can deliver new treatments and better care for all patients.
(FOTOLIA)
I'm all for women's rights, whether it's the right to go braless or even topless. This time I'm standing up for an even more serious subject: a woman's right to be a guinea pig.


I mean "guinea pig" in the best possible sense, as in being allowed to participate in clinical trials, studies that test the safety or efficacy of new drugs and therapies.

It was just 15 years ago that the National Institutes of Health (NIH) began requiring that women be included in clinical trials. Before that, groundbreaking drugs and treatments had typically been tested only on men, in spite of the fact that gender-based biological differences affect not just how women get sick and get better, but also how they respond to particular treatments.

That NIH requirement was a giant step forward, particularly for women with breast cancer, says Laura Esserman, MD, director of the Carol Franc Buck Breast Care Center at the University of California, San Francisco.

"Almost everything we've learned about women and breast cancer has come from clinical trials," says Dr. Esserman. "It's because of clinical trials that we know that modified mastectomy is as good as radical mastectomy and that older women may not need radiation."

Dr. Esserman believes that such trials lead not just to quicker approval of new lifesaving treatment options but ultimately improve the standard of care for all patients.


How to find a trial
Trials can be tough to track down. Even good oncologists don't always know of them, so it takes a particularly determined and resourceful patient to find one, says breast cancer survivor Joanne Tyler. The NIH's ClinicalTrials.gov provides data on more than 60,000 trials in 157 countries, but until recently there was no breast-cancer-specific site. So Tyler, Dr. Esserman, and another patient advocate, Joan Schreiner, created BreastCancerTrials.org.

"There are breast cancer trials that aren't accruing enough participants because they can't find them, and there are women who aren't finding the right trials," says Dr. Esserman. "BreastCancerTrials.org is like a matchmaking service that puts the two together."

The site went national just a few months ago, and it has 800 women registered already, a bit of progress that would have made Schreiner, who died in 2005, very happy, says Dr. Esserman: "Breast cancer trials are what kept Joan alive for 12 years with metastatic breast cancer. She was one of the first to try Herceptin, thanks to a clinical trial."

What participants say
Clinical trials aren't for every woman with breast cancer, but many who participate endorse them. For Connie Harrington of Aurora, Ill., who was diagnosed with stage IIIa invasive lobular carcinoma in March 2007, being part of a clinical drug trial showed that she was being as aggressive as possible. "I can say to myself that I did everything I could to treat this," she says. "It also feels good to possibly be helping women in the future."

Even women who find they weren't given the test drug or treatment during a study—like Arlene Burdette of Knoxville, Tenn., who participated in a drug trial more than five years ago—can find the experience positive. "When they told me that I'd been on the placebo, but that the study concluded that tamoxifen worked and I could go on it right away, I did," says Burdette.

When I read today that researchers at Wayne State University in Detroit have tested a breast cancer vaccine that completely eliminated HER2-positive tumors in mice, I didn't think "poor mice" (my usual knee-jerk reaction) but thought instead about what it could mean for women.

This lab already formed the model for the first vaccine that's being tested in early phase clinical trials in the United States in women with HER2-positive breast cancer. I eagerly await the day when this newer potentially lifesaving treatment can be tested by women who actually have the disease—the brave women who are exercising their right to be guinea pigs.