Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer

Sponsor
Vejle Hospital
Study ID
NCT01242449
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
    Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks
  • Vinorelbine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2010
Status verified
Mar 2015
Primary completion
Oct 31, 2012
Completion
Oct 31, 2014

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Primary Outcome Measure

Objective Response Rate [ Time Frame: Every 9 weeks. Up to 2 years ]

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