The Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital is currently participating in clinical trials researching breast cancer treatments.
"A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer" is sponsored by Imclone and will have approximately 1,113 study subjects.
In a study that began in 2008 and is projected to result in final data collection in 2015, an estimated 235 sites will participate including researchers in North and South America, Europe, Asia, Middle East, Africa, Australia and New Zealand.
With an objective of comparing the progression-free survival of the two groups, it is anticipated that the study will consist of 371 patients receiving docetaxel plus placebo and 742 patients receiving docetaxel plus IMC ramucirumab. On day one of each 21-day cycle, patients will receive docetaxel 75 mg/m2 as a one-hour I.V. infusion followed by either IMC ramucirumab 10 mg/kg or placebo 10 mg/kg as a one-hour I.V. infusion.
Each cycle is repeated every 21 days until there is evidence of progressive disease, unacceptable toxicity or other withdrawal criteria are met. Patients who discontinue study treatment with either ramucirumab or placebo may continue to receive docetaxel. Similarly, patients who discontinue docetaxel therapy may continue to receive either ramucirumab or placebo, whichever the patient was randomized to receive.
All patients will be followed for survival at regularly scheduled intervals (every six weeks until progressive disease and every six months thereafter) for at least 36 months after discontinuing study therapy.
Another trial is entitled "A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MetMAb and/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer."
Sponsored by Genentech, the study will be conducted at 50 locations in the United States, Belgium, France, Germany and Spain. Begun in 2010, the study is estimated to have final data collection in 2014 and to enroll 180 patients.
An investigational medicine currently only available through clinical trials, MetMAb is a monovalent (one-armed), monoclonal antibody designed to block Met signaling in cancer cells by binding specifically to the cell surface Met receptor, blocking HGF-mediated activation. Signaling through the HGF/Met pathway can become abnormal and cause healthy cells to become cancerous. By preventing the binding of HGF to Met, the ability of cancerous cells to grow, replicate, survive and spread is inhibited.
Primary outcome measures for the study will be progression-free survival or death on study from any cause, with the time frame from randomization to disease progression/relapse or death from any cause within 30 days of the last study treatment, whichever occurs first.
Secondary outcome measures will be objective response either complete or partial that is maintained for four weeks or longer, the duration of the response and overall survival.
In addition to participation in clinical trials, The Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital in Fort Lauderdale offers medical oncology, hematology, surgical oncology, symptom management, genetic counseling, pain management, chemotherapy, infusion therapy and radiation oncology.
