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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Stage IV Breast Cancer Drug: Trastuzumab Drug: Vinorelbine Drug: Paclitaxel Drug: Docetaxel Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.

Secondary Outcome Measures :
  1. Characterization of the time to disease progression and time to treatment failure for patients receiving trastuzumab with either vinorelbine or taxane-based chemotherapy
  2. Characterization of side effects for both treatments
  3. analysis of quality of life for patients receiving either treatment.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
North Shore Medical Center
GlaxoSmithKline
Investigators
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Principal Investigator: Harold Burstein, MD Dana-Farber Cancer Institute
More Information
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ClinicalTrials.gov Identifier: NCT00146549    
Other Study ID Numbers: 01-087
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: November 1, 2009
Last Verified: October 2009
Keywords provided by Dana-Farber Cancer Institute:
HER2-positive Breast cancer
HER2 overexpressing
trastuzumab
Herceptin
 vinorelbine
Navelbine
Taxotere
taxol
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Vinorelbine
Docetaxel
 Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological