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Phase 2
18 Years
75 Years
Not Enrolling
Carcinoma Breast Stage IV

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Trial Information

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.

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Principal Investigator

Volker Heinemann, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Munich - Klinikum Grosshadern


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Carcinoma Breast Stage IV
  • Navelbine
  • Herceptin
  • oral
  • breast cancer
  • Breast Neoplasms
  • Carcinoma