Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer

Carcinoma Breast Stage IV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433095
• Other study ID #: Mamma-2-2004
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2007
• Last updated: March 11, 2011

Study information

• Verified date: February 2007
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

1st-line treatment of HER2/neu overexpressing breast cancer

Description:

The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically proven, metastatic breats cancer.

• HER2-neu overexpression (IHC3+ or IHC2+/FISH+)

• Written informed consent

• no previous therapy with vinorelbine or trastuzumab

• Age * 18 and * 75 years

• Karnofsky-Performance status > 70%

• Life expectance 16 weeks and more

• Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions

• Exclusion of pregnancy and adequte contraception during childbearing age.

• Adequate hematological, renal, and hepatic function

• Normal cardiac function. LVEF should not be >10% below normal.

• Adequate compliance to perform treatment and subsequent follow-up visits

Exclusion Criteria:

• Locoregional recurrence of breast cancer only or development of contralateral breast cancer

• Pregnancy or lactation

• Symptomatic brain- or meningeal metastasis

• Concurrent endocrine antitumor therapy

• Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix

• Peripheral neuropathy >= NCI CTC Grade 2.

• other severel disease which preclude adequate treatment

• Participation in a clinical trial within the last 30 days.

• Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage IV

Intervention

Drug:
• Navelbine

• Herceptin

• Navelbine (oraly)

Locations

Country	Name	City	State
Germany	University of Munich - Klinikum Grosshdern	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Pierre Fabre Laboratories

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate
Secondary	Time to tumor progression
Secondary	Overall survival
Secondary	Safety