A Phase II Trial of Panitumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer
All patients will receive a pre-emptive skin care regimen during panitumumab therapy to
reduce skin toxicity. Treatment cycles will be repeated every 14 days (2 weeks). During each
treatment, panitumumab will be administered first, then carboplatin, then gemcitabine. All
drugs will be administered according to standard guidelines. Patients will be re-evaluated
for response after completion of 3 cycles (6 weeks) of treatment. Patients with objective
response or stable disease will continue treatment. Subsequent re-evaluations will occur
every 6 weeks. Patients will continue treatment with all three drugs until tumor
progression, or until unacceptable toxicity occurs. If patients experience toxicity caused
by gemcitabine/carboplatin and are continuing to benefit from treatment, panitumumab can be
continued as a single agent (at the same dose and schedule), at the discretion of the
investigator, until disease progression occurs.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the progression-free survival (PFS) of patients with triple-negative metastatic breast cancer when treated with panitumumab, gemcitabine, and carboplatin
18 months
No
Denise A Yardley, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI BRE 126
NCT00894504
February 2010
December 2012
Name | Location |
---|---|
Atlantic Health System | Summit, New Jersey 07901 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Research Medical Center | Kansas City, Missouri 64132 |
Family Cancer Center | Collierville, Tennessee 38017 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Providence Medical Group | Terre Haute, Indiana 47802 |
Norton Cancer Institute | Louisville, Kentucky 40207 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
Nebraska Methodist Cancer Center | Omaha, Nebraska 68114 |
Aventura Hospital and Medical Center | Aventura, Florida 33180 |
Texas Health Physician Group | Dallas, Texas 76011 |