Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: herceptinProcedure: conventional surgeryProcedure: radiation therapy
- Registration Number
- NCT00118053
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel, Carboplatin and Trastuzumab herceptin 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. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks. Docetaxel, Carboplatin and Trastuzumab conventional surgery 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. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks. Docetaxel, Carboplatin and Trastuzumab radiation therapy 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. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks. Docetaxel, Carboplatin and Trastuzumab carboplatin 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. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks. Docetaxel, Carboplatin and Trastuzumab docetaxel 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. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.
- Primary Outcome Measures
Name Time Method Antitumor Activity as Measured by Response Rate 5 years
- Secondary Outcome Measures
Name Time Method Pathological Complete Response 5 years Disease-free Survival 10 years Pathologic and Molecular Markers for Predicting Efficacy 5 years
Trial Locations
- Locations (9)
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
UMDNJ University Hospital
🇺🇸Newark, New Jersey, United States
Mountainside Hospital Cancer Center
🇺🇸Montclair, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
CentraState Medical Center
🇺🇸Freehold, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸Hamilton, New Jersey, United States
Central Jersey Oncology Center, PA - East Brunswick
🇺🇸East Brunswick, New Jersey, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States