Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00146549|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : November 1, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage IV Breast Cancer||Drug: Trastuzumab Drug: Vinorelbine Drug: Paclitaxel Drug: Docetaxel||Phase 3|
- All patients will receive trastuzumab then be randomized into one of two arms. Arm A: Trastuzumab in combination with weekly vinorelbine and Arm B: Trastuzumab in combination with a weekly taxane-based regimen, either paclitaxel or docetaxel, chosen at the discretion of the investigator.
- Treatment is administered on an outpatient basis. Trastuzumab is administered weekly. There is a one-time loading dose for the first week of the first cycle. For that initial treatment, only, the trastuzumab dose is 4mg/kg. The dose for all subsequent weekly trastuzumab treatments is 2mg/kg.
- Arm A: vinorelbine is administered every week and the dose is adjusted based on the absolute neutrophil count for that week. Vinorelbine is given after trastuzumab.
- Arm B: Either paclitaxel given weekly (dose bases on absolute neutrophil count) or docetaxel given on weeks 1,2,3,5,6,7 of each 8-week cycle (dose based upon absolute neutrophil count). Patients on paclitaxel will also receive dexamethasone, diphenhydramine and ranitidine to help prevent allergic or hypersensitivity reactions. Patients on docetaxel will receive dexamethasone to help reduce fluid retention or edema.
- Every 8 weeks the patients cancer will be re-evaluated to see if the treatment is working. If the treatment appears to be working, treatment will continue. Standard radiological testing (x-rays, CT scan, radioactive drug scans, or MRI's) will be used to follow the disease treatment.
- Heart function will be measured after 16 weeks to be sure it is safe to continue treatment.
- Every 8 weeks, patients' will be asked to complete a brief written survey that asks about symptoms and side effects.
- Patients' will remain on the treatment as long as there is no disease progression or unacceptable side effects.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||December 2007|
- To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.
- Characterization of the time to disease progression and time to treatment failure for patients receiving trastuzumab with either vinorelbine or taxane-based chemotherapy
- Characterization of side effects for both treatments
- analysis of quality of life for patients receiving either treatment.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
- Tumors must be HER2 overexpressing
- Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
- 18 years of age or older
- Life expectancy of greater than 6 months
- ECOG performance status of 0-2
- ANC count > 1,500/mm3
- Platelets > 100,000/mm3
- Total bilirubin < 1.5 mg/dl
- AST/ALT < 115 U/I
- Creatinine < 2.0 mg/dl
- Glucose < 200 mg/dl
- LVEF > 50%
- Prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer
- Concurrent hormonal therapy, chemotherapy, or radiation treatments
- Pregnant or lactating women
- Known brain metastases or leptomeningeal carcinomatosis
- History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to the agents in this study
- Pre-existing neuropathy from any cause in excess of grade 1
- Uncontrolled intercurrent illness
- History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer
- Patients taking macrolide antibiotics, ketoconazole, or AZT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146549
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Harold Burstein, MD||Dana-Farber Cancer Institute|
|Other Study ID Numbers:||
|First Posted:||September 7, 2005 Key Record Dates|
|Last Update Posted:||November 1, 2009|
|Last Verified:||October 2009|
HER2-positive Breast cancer
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological