Study to assess the efficacy and safety of oral vinorelbine in combination with capecitabine in patients suffering from breast cancer previously treated with other chemotherapies (anthracyclines, and taxanes)

Phase II study of oral vinorelbine in combination with capecitabine in metastatic breast cancer patients previously treated with anthracyclines and taxanes - Not applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000665-35-ES

Enrollment

Registered

2012-04-13

Start date

2004-09-08

Completion date

Unknown

Last updated

2022-04-19

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 women previously treated with anthracyclines and taxanes

Interventions

Trade Name: Navelbine Capsulas blandas Product Name: Navelbine Cápsulas Blandas Product Code: Not applicable Pharmaceutical Form: Capsule, soft INN or Proposed INN: Vinorelbine tartrate CAS Number: No

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women aged 18 to 75 years, documented metastatic breast disease, at least one bidimensionally measurable lesion adequately measured by imaging procedure, previously treated with anthracyclines and taxanes, Karnofsky performance status of 70 or greater, adequate haematological, hepatic and renal functions. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: Patient with poor prognosis disease, pregnant or lacting or of childbearing potential not using adequate contraception, malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade 2 or more dysphagia, other serious illness or medical conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the response rate of oral vinrelbine (60 mg/m²/week) combined with capecitabine 2000 mg/m²/day from day 1 to day 14 every 3 weeks.;Secondary Objective: To evaluate the safety profile, the duration of response, progression free-survival, overall survival and quality of life.;Primary end point(s): To evaluate the response rate of oral vinrelbine (60 mg/m²/week) combined with capecitabine 2000 mg/m²/day from day 1 to day 14 every 3 weeks.;Timepoint(s) of evaluation of this end point: The patients were followed during the 30 days after their last study treatment administration. Survival information was collected approximately every 3 months until death.	—

Measure

Time frame

Main Objective: To evaluate the response rate of oral vinrelbine (60 mg/m²/week) combined with capecitabine 2000 mg/m²/day from day 1 to day 14 every 3 weeks.;Secondary Objective: To evaluate the safety profile, the duration of response, progression free-survival, overall survival and quality of life.;Primary end point(s): To evaluate the response rate of oral vinrelbine (60 mg/m²/week) combined with capecitabine 2000 mg/m²/day from day 1 to day 14 every 3 weeks.;Timepoint(s) of evaluation of this end point: The patients were followed during the 30 days after their last study treatment administration. Survival information was collected approximately every 3 months until death.

—

Secondary

Measure	Time frame
Secondary end point(s): Safety and Quality of Life;Timepoint(s) of evaluation of this end point: Safety : The patients were followed during the 30 days after their last study treatment administration. Survival information was collected approximately every 3 months until death. Quality of Life: questionnaires were to be filled in every two treatment cycles.	—

Countries

Spain

Contacts

Public ContactMaud Brandely

Pierre Fabre Medicament

maud.brandely@pierre-fabre.com0033149 10 82 45

Outcome results

None listed

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