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Trial offers new breast cancer treatment

March 22, 2011 12:00:00 AM PDT
Women with advanced breast cancer are often faced with difficult choices, because treatments can come with dangerous side effects and poor outcomes. But a more personalized approach gives patients a more tolerable and effective treatment.

Piper Denlinger lights up on the job.

"I love my job. I am so lucky. I have the best job in the best fire department in the United States," said Denlinger.

When the call comes in, she jumps behind the wheel. But a few months ago, she got a call while on duty that changed her life: She had stage 2 breast cancer.

"The real emotional hard part was the next morning, getting up out here before everybody else got up in the morning, and to see the fire engine and realize that was going to be the last time I was going to drive that fire engine for a long time," said Denlinger.

The 47-year-old is now part of a clinical trial called I-SPY at the University of California-San Diego health system. They're using chemotherapy plus biological agents to target and wipe out cancer before surgery.

"It's not so much killing cells as changing them so they then cannot go on to duplicate and become worse and worse and worse," said Dr. Anne Marie Wallace, a breast-cancer surgeon.

Doctors use MRIs and biopsies to constantly monitor the tumors, and they are able to see how the medication is working and adjust it. Typical clinical trials take 10 to 15 years to determine if drugs are working. I-SPY's feedback is immediate.

"What you do do though is shrink the tumor enough that up to 60 percent of the time that you thought you were going to actually have to remove the breast, you can instead just do a lumpectomy," said Dr. Wallace.

Three weeks into Denlinger's treatment, her tumor has already gotten smaller.

"The fact that this little pill that I'm taking every day right now is designed specifically for what I've got, that's amazing," said Denlinger.

Although she still suffers nausea and exhaustion, Denlinger was feeling well enough to make her first trip back to the firehouse since her diagnosis. It comes just a day after another breast cancer milestone: She shaved her head the night before.

"It's just another stage," said Denlinger. "And what it means is that every stage that I go through means one more stage to get back to work, gets me back whole."

And the guys are ready to get her back as well.

A true fighter, on and off the job.

Denlinger hopes to be back to work full-time by September.

The I-SPY trial is for patients with tumors the size of an inch.

BACKGROUND: The main goal of the I-SPY clinical trial is to speed up treatment for breast cancer. The information learned in the I-SPY trial will help physicians provide a better prognosis for breast cancer patients and help them select more effective treatments. Researchers also hope to reduce the cost and time it takes to get promising new drugs to the market. I-SPY is a multi-center clinical trial, which is designed to evaluate the impact of chemotherapy before advanced patients undergo surgery. (SOURCE: www.ncicb.nci.nih.gov)

I-SPY 1 TRIAL: The I-SPY 1 trial started in 2003. The goal was to see if researchers could predict how a patient would respond to neoadjuvant chemotherapy (chemotherapy given to reduce tumor size, before surgery) using multiple MRI scans and biomarkers (characteristics of a cell that provide information about how the cell is behaving). Researchers didn't use any investigational drugs in I-SPY 1. Instead, the trial involved serial imaging and tissue collection from women with tumors at least three centimeters in size. (SOURCE: ispy2.org/about.com)

I-SPY 1 FINDINGS: Researchers found that most locally advanced breast cancers are discovered in between routine mammogram exams, which usually happen every one or two years. Therefore, investigators say women should not ignore a growing breast mass, even if there is a recent normal mammogram. Researchers also found the response to therapy and outcome can be predicted by many biomarkers. (SOURCE: www.cancernetwork.com)

I-SPY 2 TRIAL: The second phase of the trial, I-SPY 2, was launched in March of 2010. The goal of I-SPY 2 is to take what researchers learned in I-SPY 1 and test which investigational drugs benefit patients. I-SPY 2 has the potential to reduce the costs of drug development and speed up the process of getting promising drugs to the market. The trial will screen multiple cancer drugs from multiple companies. Researchers will use the drugs and standard neoadjuvant chemotherapy to learn which new drug agents are most beneficial for women with certain tumor characteristics. They also hope to eliminate ineffective treatments more quickly. Researchers hope to test more than 800 patients over a four-year period. I-SPY 2 is still enrolling women with newly diagnosed invasive breast cancer. To find out more about how to participate visit www.ispy2.org/about.com.