A Randomised Phase II study of Oral Vinorelbine or I.V. Vinorelbine in patients with metastatic breast cancer previously treated with anthracyclines

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000963-81-AT

Enrollment

230

Registered

2004-11-10

Start date

2004-11-15

Completion date

Unknown

Last updated

2013-04-15

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

Conditions

Treatment in metastatic breast cancer previously treated with anthracyclines

Interventions

Trade Name: Navelbine Soft Capsules Product Name: Navelbine Soft Capsules Pharmaceutical Form: Capsule, soft INN or Proposed INN: Vinorelbine tartrate CAS Number: 125317-39-7 Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women over 65 years - Prior therapy with anthracyclines - Documented metastatic breast cancer - Karnofsky Performance Status not less than 70% - Presence of at least one measurable lesion according to RECIST criteria - Adequate haematological, hepatic and renal function Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) 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: - Patients with life-threatening conditions - Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade not less than 2 dysphagia - Other serious illness or medical condition

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of oral vinorelbine in patients with metastatic breast cancer previously treated with anthracyclines, in terms of tumour response.;Secondary Objective: To assess the tumour response rate in the IV vinorelbine arm To determine the progression-free survival and the overall survival in both arms To evaluate the safety of oral and i.v. vinorelbine To assess the quality of life in each treatment arm;Primary end point(s): To determine the efficacy of oral vinorelbine in patients with metastatic breast cancer previously treated with anthracyclines, in terms of tumour response	—

Measure

Time frame

Main Objective: To determine the efficacy of oral vinorelbine in patients with metastatic breast cancer previously treated with anthracyclines, in terms of tumour response.;Secondary Objective: To assess the tumour response rate in the IV vinorelbine arm To determine the progression-free survival and the overall survival in both arms To evaluate the safety of oral and i.v. vinorelbine To assess the quality of life in each treatment arm;Primary end point(s): To determine the efficacy of oral vinorelbine in patients with metastatic breast cancer previously treated with anthracyclines, in terms of tumour response

—

Countries

Austria

Outcome results

None listed

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