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CompletedNCT00193089Updated Dec 10, 2015

Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

A Phase 2 interventional study of Docetaxel and Vinorelbine in Breast Cancer, sponsored by SCRI Development Innovations, LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-10.

Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Read the detailed description

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Metastatic breast cancer confirmed by biopsy
  • Overexpression of the Her-2 oncogene
  • Age > 18 years
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • No previous chemotherapy for metastatic disease
  • One or more previous hormonal therapies for metastatic disease.
  • Adequate bone marrow, liver and kidney function
  • Patients with \< grade 1 peripheral neuropathy are eligible.
  • Must give written informed consent prior to entering this study.

Exclusion criteria

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Abnormal heart function
  • Previous treatment with trastuzumab
  • Brain metastases untreated
  • Pre-existing symptomatic peripheral neuropathy
  • Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

  • DrugDocetaxel

    Docetaxel

  • DrugVinorelbine

    Vinorelbine

  • DrugTrastuzumab

    Trastuzumab

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What researchers measure

Primary outcomes

  1. feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.

    Time frame: 18 Months

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Infante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer. 2009 Feb;9(1):23-8. doi: 10.3816/CBC.2009.n.004. PubMed 19299236 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00193089
Lead sponsor
SCRI Development Innovations, LLC
Collaborators
Aventis Pharmaceuticals, GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 19, 2005
Start date
Apr 2001
Primary completion
Apr 2005
Completion
Sep 2009
Last update
Dec 10, 2015

Study contacts

John D. Hainsworth, MD
principal investigator · SCRI Development Innovations, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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