A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer
In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been
in use for a long time. Gemcitabine is a treatment that is an effective therapy currently
available to patients with this type and stage of breast cancer. Frequently, in cancer
therapy, combinations of drugs prove more effective as treatment than the same drugs used
alone. The combination of gemcitabine and oxaliplatin has not been tested in patients with
triple negative breast cancer. It is hoped that the addition of oxaliplatin may cause your
tumor to stop growing or possible your tumor may shrink. This assessment will be basd on
measuring changes in the size of your tumor.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.
A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Amelia Zelnak, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|