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

NCT00433095 | Completed Phase 2

• 1 other identifier: Mamma-2-2004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma Breast Stage IV

Keywords

Navelbine; Herceptin; oral; breast cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

Secondary Outcomes (3)

• Time to tumor progression

• Overall survival

• Safety

Interventions

Navelbine DRUG

Herceptin DRUG

Navelbine (oraly) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Pierre Fabre Laboratories: collaborator

Study Sites (1)

University of Munich - Klinikum Grosshdern

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Volker Heinemann, PhD, MD

  University of Munich - Klinikum Grosshadern

  PRINCIPAL INVESTIGATOR

• Hans-Joachim Stemmler, PhD, MD

  University of Munich - Klinikum Grosshadern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 9, 2007
• Last Updated: March 14, 2011

Record last verified: 2007-02

Locations

DE (1)