Clinical trials underway at Broward Health Broward General Medical Center (BGMC) are exploring ways to improve treatment modalities for patients diagnosed with breast cancer.

Discoveries are constantly being added to the science of treating breast cancer through various clinical trials and research designed to find ways to improve quality of life and overall survival.

 

“Today, cancer is increasingly perceived to be a diagnosis – and not necessarily a death sentence,” says Archana Maini, M.D., hematologist/oncologist, Comprehensive Cancer Center, BGMC, and clinical assistant professor at Nova Southeastern University. “Clinical trials allow patients to benefit from the studies conducted in the past and contribute to future benefits for more patients. All medications for breast cancer now being utilized are based on what has been learned through clinical trials.”

 

Open clinical trials related to breast health are underway at BGMC, each utilizing a unique medication, such as Avastin® and Herceptin®.

 

Avastin – Traditionally, women who have limited diseases such as non-metastatic breast cancer are given chemotherapy only after surgery. The medication currently in clinical trial is Avastin (bevacizumab). Cytoxan® and Adriamycin® – one combination of chemotherapy medications – are usually given every two or three weeks for about four cycles. After completion, a dose-dense paclitaxel is prescribed four cycles of the first two followed by four cycles of the second.

 

As part of the clinical trial, participants will be divided into three groups: Group A will be given Cytoxan and Adriamycin with a placebo followed by paclitaxel; Group B will receive Cytoxan and Adriamycin with Avastin; and Group C will be treated as indicated above in addition to being given Avastin by itself for an additional 10 cycles.

 

“This clinical trial is investigating if Avastin is helpful in treating non-metastatic cancer since it is already approved for patients with metastatic cancer,” Dr. Maini says. “If found effective, this will be a great stride forward.”

 

The planned number of participants is 4,950, with more than 4,000 people already recruited.

 

Herceptin – Another clinical trial at BGMC is studying if Herceptin is the only effective treatment for women with the human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic breast cancer.

 

“Some breast cancers may not express any receptors, while others may,” says Dr. Maini. “Patients with breast cancer who express the HER2 gene are at a higher risk for a more aggressive cancer. Although the U.S. Food and Drug Administration has already approved an effective drug [Herceptin] for these patients, this study wants to show if neratinib following Herceptin is more beneficial.”

 

After finishing a year of Herceptin, participants in this trial will be divided into two groups, with one receiving neratinib and the other a placebo. “Until now, the standard of care was to finish treatment after one year of Herceptin,” says Dr. Maini. “However, these women are at greater risk of recurrence due to the aggressiveness of this type of breast cancer. Researchers therefore want to examine if giving patients neratinib for another year would lead to better long-term survival rates.”

 

At BGMC, chemotherapy remains the mainstay medical response to metastatic cancer. The hope is that new treatments currently in clinical trials may present effective alternatives.