Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
North Shore Medical Center
GlaxoSmithKline
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146549
First received: September 2, 2005
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Breast Cancer
Stage IV Breast Cancer
Drug: Trastuzumab
Drug: Vinorelbine
Drug: Paclitaxel
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 250
Study Start Date: August 2001
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146549

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
North Shore Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Harold Burstein, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00146549     History of Changes
Other Study ID Numbers: 01-087
Study First Received: September 2, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
HER2-positive Breast cancer
HER2 overexpressing
trastuzumab
Herceptin
vinorelbine
Navelbine
Taxotere
taxol

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Vinorelbine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 22, 2014