The Long and Winding Road

One Woman's Journey Through Clinical Trials

When she was diagnosed with breast cancer the first time, the furthest thing from Julie Maas' mind was a clinical trial. She was a working, single mom with two boys, ages 3 and 5.

After surgery and radiation, Richard Theriault, D.O., professor in the Department of Breast Medical Oncology at M. D. Anderson, offered Maas three clinical trials. But her thought was, "I'm at Stage I. The cancer is gone. I know chemotherapy is an insurance policy, but I want to get it over with quickly and get on with my life."

That was in 1992.

Clinical trials provide options

Then, in 2002, she began experiencing shortness of breath and a cough and was diagnosed with asthma. Medication didn't help and X-rays showed fluid on the lungs.

Theriault compared the cells in the fluid with her original cancer cells. She was diagnosed with recurrent hormone-positive metastatic breast cancer.

Having a disease that was not curable but chronic made her open to clinical trials.

"When I started in medicine a few years back," Theriault says, "the standard treatment for breast cancer was a radical mastectomy and radiation. Because of clinical research almost no one has that nowadays. In addition, as a consequence of new drug development and application of new techniques, the death rate from breast cancer has decreased each year for the last four years. I think we've been very successful, though we're not resting on our laurels."

Rocky roads turn to smoother pathways

Maas' odyssey reflects these advances, as well as the challenges that metastatic disease brings. For 2 years, she has alternated between standard treatments and clinical trials, thankful for the options research has given her.

The constant monitoring of tumor markers (substances found in increased amounts in some cancer patients) has determined the efficacy of each treatment. When Maas was diagnosed in August 2002, her tumor marker was 172.6 (normal is 0-38).

Her long and winding road

August-October 2002:Tried Femara (letrozole), an aromatase inhibitor that suppresses the production of estrogen, a major growth factor in hormone-receptor positive breast cancer. This fairly standard treatment failed her.

November 2002-January 2003:Entered a clinical trial for Faslodex (fulvestrant), a new drug found to target and degrade estrogen receptors present in breast cancer cells. Her tumor markers edged up 10, sometimes 20, points after each treatment.

"That's when Dr. Theriault told me, 'I'm going to start you on chemotherapy, and I want you to start tonight,' " Maas says. "This was at 4 p.m. I told him I still had two boys at home, dinner to cook and homework to get started. He said, 'Your boys will thank me. You start at 7 o'clock.' "

February-June 2003:Began taking Taxol, a fairly standard chemotherapy treatment that prevents the growth of cancer cells in some patients. Her tumor markers dropped 20 points, stabilized and then began to creep up. By the end of May, a CT scan showed lesions in Maas' liver. "Dr. Theriault said the bad news was that Taxol wasn't working."

The good news was she was eligible for three clinical trials.

July 2003:Entered a Phase II study of tariquidar (XR9756) with Taxol. Her tumor markers went down, but the trial was stopped due to cardiac toxicity.

August 2003:Went back to standard chemotherapy she successfully used in 1992, FAC (5-FU, adriamycin and cytoxin). Her tumor markers shot up hundreds of points after only two treatments. "It was like throwing fertilizer on my cancer cells," Maas says.

September 2003-March 2004:Entered a clinical trial using Epothilone B in combination with Xeloda (capecitabine).

"When I was signing the consent form, I asked Dr. Theriault what the percentages are that this trial is going to work, and he said 40%. I liked those numbers." After eight treatments, Maas' tumor markers were down to 42 and she was ecstatic.

April 2004-present:She takes Xeloda.

"I feel great," Mass says today. "I don't have any more pain like I had. No shortness of breath. Lots of energy. I'm enjoying the sun coming up in the morning and setting in the evening. I'm enjoying my boys as much as I can. I know someday I'm going to face more treatment. By that time, I know there will be other clinical trials available at M. D. Anderson."