A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer
- Determine the antitumor activity of trastuzumab (Herceptin^®), docetaxel, and
carboplatin, as measured by tumor response rate, in women with previously untreated
HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer.
- Determine the pathological complete response in patients treated with this regimen.
- Determine the disease-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine pathologic and molecular markers for predicting efficacy of this regimen in
OUTLINE: This is a non-randomized, multicenter study.
- Course 1 (days 1-28): Patients receive trastuzumab (Herceptin^®) IV over 30-90 minutes
on days 1, 8, 15, and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60
minutes on day 8.
- Course 2-6: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 during
courses 2-5 and on days 1, 8, 15, and 22 during course 6. Patients also receive
docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1. Treatment
repeats every 21 days for 5 additional courses (6 courses total) in the absence of
disease progression or unacceptable toxicity.
Three weeks after completion of course 6, patients undergo restaging. Patients with local
operable disease undergo modified radical mastectomy or lumpectomy and axillary node
dissection followed by radiotherapy. Patients also receive trastuzumab IV once every 3 weeks
for up to 52 weeks of total treatment (including the 6 courses of trastuzumab, docetaxel,
and carboplatin) in the absence of disease progression or unacceptable toxicity. Patients
who do not have local operable disease continue to receive trastuzumab as above.
PROJECTED ACCRUAL: A total of 13-43 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Treatment
Deborah L. Toppmeyer, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Overlook Hospital||Summit, New Jersey 07902-0220|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Morristown, New Jersey 07962|
|UMDNJ University Hospital||Newark, New Jersey 07103|
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Saint Peter's University Hospital||New Brunswick, New Jersey 08901-1780|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Mountainside Hospital Cancer Center||Montclair, New Jersey 07042|
|CentraState Medical Center||Freehold, New Jersey 07728|
|Central Jersey Oncology Center, PA - East Brunswick||East Brunswick, New Jersey 08816|