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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
Massachusetts General Hospital
Brigham and Women's Hospital
North Shore Medical Center
Information provided by:
Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date November 1, 2009
Study Start Date  ICMJE August 2001
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Official Title  ICMJE 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
Brief Summary The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.
Detailed Description
  • 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Stage IV Breast Cancer
Intervention  ICMJE
  • Drug: Trastuzumab
  • Drug: Vinorelbine
  • Drug: Paclitaxel
  • Drug: Docetaxel
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 2, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00146549
Other Study ID Numbers  ICMJE 01-087
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dana-Farber Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • North Shore Medical Center
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Harold Burstein, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP