Clinical trials offer options for cancer patients


“You might live three to five years.”

Those were the words that greeted Stephanie Story when she met with the specialist she’d been referred to after her second diagnosis of breast cancer.

That was in 2009.

Today she is alive and well and managing her breast cancer with the help of Afinitor. Back when she started taking the oral drug therapy, it was referred to as RAD-001. She took the medication after first-line therapy failed to address what had developed into metastatic disease as a participant in a clinical trial. It was conducted through the Provision Center for Biomedical Research in partnership with Tennessee Cancer Specialists.

“I was considered stage 4, and my prognosis was not good,” Story said.

She began taking the drug as part of a regimen that included chemotherapy, from which Story succumbed to terrible neuropathy and had to stop the regimen.

Afinitor, on the other hand, “is a different class of drug,” said Susie Owenby, clinical research manager with the Center for Biomedical Research. “It’s a whole lot easier to take.”

Story remains on the daily medication, which was Food and Drug Administration approved several years ago, and has seen a 50 percent reduction in the presence of cancer in her body.

“Basically, I have been stable since 2011,” she said. “Like I say, I’ve outlived my expiration date.”

CBR gives local patients new treatment opportunities

The Provision Center for Biomedical Research has managed hundreds of clinical trials, with a particular focus on medical oncology, proton therapy and PET imaging. The center is regionally noted for its expertise in conducting pharmaceutical trials targeting smaller, rare cancer subsets with specific tumor mutations. The center and its oncology partners are often selected by major pharmaceutical sponsors and clinical research organizations as a regional clinical research site for their most promising cancer therapeutics.

Patients participate in Phase 1, 2 or 3 trials. Drug trials typically start with very small groups of patients in Phase 1 and help determine proper dosage and side effects. Phase 2 groups are larger and focus more exclusively on the cancer’s response to treatment. Phase 3 trials are double-blinded and serve as the last step before a drug is made available to all patients. Story participated in a Phase 2 study.

The Center for Biomedical Research is a member of the National Cancer Institute’s National Clinical Trial Network as well as the following NCI groups: NRG Oncology, Eastern Cooperative Oncology Group, Children’s Oncology Group and Cancer Trials Support Unit.

In addition, the biomedical center manages a clinical registry of its own, working with other proton centers to gather data on outcomes of proton therapy treatment—information that will assist in development better treatment protocols and expanding the available of proton therapy.

The Provision Center for Biomedical Research is currently participating in 18 studies ranging from cancer drugs for all major cancers to pulmonary and urinary treatments to radiation therapy. The Center has 50-60 patients participating in its open clinical trials.

Not all up-and-coming therapies work for all patients. But Story believes the availability of a local clinical trial has been lifesaving.

“I am grateful for every day,” she said.