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Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer

NCT01242449 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-05-21

No results posted yet for this study

Summary

This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer.

Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.

Conditions

Interventions

DRUG

Trastuzumab

Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks

DRUG

Vinorelbine

Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home.

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Troels Bechmann, MD · Department of Oncology, Vejle Hospital

  • Erik H Jakobsen, MD · Department of Oncology, Vejle Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-10-31
Completion
2014-10-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242449 on ClinicalTrials.gov