“I had 18 grueling months of breast cancer treatment: a mastectomy, chemotherapy, radiation, and eventually the drug Herceptin,” says Kristine Kulowiec. “The treatment left me fatigued and in pain. I couldn’t work and couldn’t even go out to restaurants with my husband.” Although her body seemed to be responding to this onslaught of treatments, in 2006 Kulowiec learned her tumor had metastasized to her liver.

“I wanted to give up, but my oncologist at Duke, Dr. Kim Blackwell, was excited about a clinical trial she was conducting for the drug Tykerb,” explains Kulowiec.

Her body began responding to the new treatment almost immediately. In the first 16 weeks, her tumor had been significantly reduced. Nine months after she began taking Tykerb, Kulowiec went white water rafting for the first time since her diagnosis in 2003.

“I have my life back because of Tykerb. I’ve gone skiing, horseback riding, and completed the Komen Race for the Cure under my goal of 45 minutes. My energy level is higher,” says Kulowiec. “I originally came to Duke for a second opinion and decided to get treated here because it was where I felt most comfortable. I’m thankful that Duke offers so many clinical trials. That’s one of the reasons I’ve been traveling nearly two hours roundtrip to get treated.”

Tykerb was approved by the Food and Drug Administration in March 2007, to be used with the chemotherapy agent Xeloda, for patients with advanced or metastatic breast cancer who have the overexpressed HER2 gene -- about a quarter of breast cancer cases. Tykerb is for women who have not responded to other treatments. The FDA gave the oral drug “fast-track” status to expedite the review process because of the benefits proven through the clinical trials.

Kristine Kulowiec skiing after she began taking TykerbDuke’s Director of Translational Research in Oncology, Neil Spector, MD, led the development of Tykerb while at GlaxoSmithKline (GSK). He left GSK to join Duke in September of 2006.

“Not only has Tykerb proved effective in treating women with breast cancer, but recent research indicates the drug may be safer for the heart than the frequently prescribed breast cancer drug Herceptin,” says Spector. Ten percent of patients are unable to take Herceptin because of the risk of heart damage, according to a study by Spector published in June 2007 in the Proceedings of the National Academy of Sciences.