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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: vinorelbine ditartrate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 1999
Actual Primary Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • 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

Information from the National Library of Medicine

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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 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

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 identifier (NCT number): NCT00014430

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United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
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Study Chair: Peter A. Kaufman, MD Norris Cotton Cancer Center

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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00014430     History of Changes
Other Study ID Numbers: CDR0000068543
P30CA023108 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: November 2002

Keywords provided by Dartmouth-Hitchcock Medical Center:
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action