VINORELBINE AND CAPECITABINE as first line treatment in advanced breast cancer patients with non measurable lesions for RECIST criteria - VNBCAP

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005680-29-IT

Enrollment

100

Registered

2007-02-22

Start date

2006-02-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic breast cancer MedDRA version: 6.1 Level: PT Classification code 10055113

Interventions

Trade Name: Navelbine 10IV 10mg 1ml Product Name: vinorelbina Pharmaceutical Form: Solution for infusion INN or Proposed INN: Vinorelbine Current Sponsor code: VNBCAP Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: metastatic breast carcinoma non measurable lesions for RECIST criteria progression after loco-regional therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: previous first line chemotherapy previous second and third line hormonotherapy for advanced disease diagnosis of advanced disease with only elevated markers

Design outcomes

Primary

Measure	Time frame
Main Objective: time to progression;Secondary Objective: toxicity quality of life overall survival;Primary end point(s): time to progression from th entry into the study until first clinial or instrumental disease progression	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026