Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.
Procedure: conventional surgery
Procedure: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer|
- Antitumor Activity as Measured by Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Pathological Complete Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Disease-free Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Pathologic and Molecular Markers for Predicting Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel, Carboplatin and Trastuzumab
A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Other Name: trastuzumbDrug: carboplatin Drug: docetaxel
Other Name: TaxotereProcedure: conventional surgery
Modified radical mastectomy or lumpectomy and axillary node dissectionProcedure: radiation therapy
Whole breast or chest wall irradiation (as determined by radiologist)
- 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 these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118053
|United States, New Jersey|
|Central Jersey Oncology Center, PA - East Brunswick|
|East Brunswick, New Jersey, United States, 08816|
|CentraState Medical Center|
|Freehold, New Jersey, United States, 07728|
|Cancer Institute of New Jersey at Hamilton|
|Hamilton, New Jersey, United States, 08690|
|Mountainside Hospital Cancer Center|
|Montclair, New Jersey, United States, 07042|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962-1956|
|Saint Peter's University Hospital|
|New Brunswick, New Jersey, United States, 08901-1780|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|UMDNJ University Hospital|
|Newark, New Jersey, United States, 07103|
|Summit, New Jersey, United States, 07902-0220|
|Principal Investigator:||Deborah L. Toppmeyer, MD||Rutgers Cancer Institute of New Jersey|