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Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014430
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : March 14, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE April 10, 2001
First Posted Date  ICMJE February 16, 2004
Last Update Posted Date March 14, 2013
Study Start Date  ICMJE November 1999
Actual Primary Completion Date September 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00014430 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
Official Title  ICMJE Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer.

Detailed Description


  • Determine the maximum tolerated dose of vinorelbine in combination with trastuzumab (Herceptin) in patients with HER-2/neu overexpressing unresectable or metastatic non-small cell lung cancer (closed to accrual as of 4/16/01) or refractory locally advanced or metastatic breast cancer.
  • Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this patient population.
  • Determine the objective response rate of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of vinorelbine.

Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8, and trastuzumab (Herceptin) IV over 30-90 minutes on days 8 and 15 of course 1 and days 1, 8, and 15 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 to 6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 30-35 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: trastuzumab

    Trastuzumab (INN; trade name Herceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.

    The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell to inside the cell, and turn genes on and off. The HER proteins regulate cell growth, survival, adhesion, migration, and differentiation—functions that are amplified or weakened in cancer cells. In some cancers, notably some breast cancers, HER2 is over-expressed, and causes breast cells to reproduce uncontrollably.

    Other Name: herceptin
  • Drug: vinorelbine ditartrate
    Vinorelbine (trade name Navelbine) is an anti-mitotic chemotherapy drug that is given as a treatment for some types of cancer, including breast cancer and non-small cell lung cancer.
    Other Name: Navelbine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March¬†12,¬†2013)
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically confirmed unresectable or metastatic non-small cell lung cancer

    • Stage IIIB or IV (closed to accrual as of 4/16/01) OR
  • Histologically confirmed locally advanced breast cancer that has progressed after first-line chemotherapy or metastatic breast cancer
  • HER-2/neu overexpression (1+ to 3+)
  • Hormone receptor status:

    • Not specified



  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • ALT no greater than 3 times ULN


  • Creatinine no greater than 2 times ULN


  • No prior or concurrent unstable angina
  • No prior symptomatic congestive heart failure
  • No myocardial infarction within the past 6 months
  • LVEF at least 45% by echocardiogram or MUGA if received prior anthracycline or anthrapyrazole therapy


  • No prior hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of these products
  • No other medical illness that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior trastuzumab (Herceptin)


  • See Disease Characteristics
  • No prior vinorelbine

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified
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 NCT00014430
Other Study ID Numbers  ICMJE CDR0000068543
P30CA023108 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Peter A. Kaufman, MD Norris Cotton Cancer Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date November 2002

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