Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000748-26-ES

Enrollment

Registered

2004-10-13

Start date

2004-11-08

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Treatment in women with previously untreated HER2 positive metastatic breast cancer.

Interventions

Trade Name: Navelbine Cápsulas Blandas Product Name: Navelbine Cápsulas Blandas Product Code: Not applicable Pharmaceutical Form: Capsule, soft INN or Proposed INN: Vinorelbine tartrate CAS Number: N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women with age not less than 18 years, Documented metastatic breast disease previously untreated by chemotherapy, HER2 positive (assessed by 3+IHC or FISH+) on the primary tumor or on metastatic site, At least one measurable lesion using the RECIST criteria, Be ambulatory with a Karnofsky Performance Status not less than 70%, Life expectancy not less than 16 weeks, Normal cardiac function, LVEF not less than 50% as measured by MUGA scan or ultrasound, Adequate bone marrow, 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Local relapse alone after conservative treatment of contra-lateral tumor, Pregnant or lactating women, Patient with symptoms suggesting CNS involvment or leptomeningeal metastases, Concomitant hormone therapy for metastatic breast cancer, Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of capecitabine (Xeloda) and oral vinorelbine (Navelbine Oral), Other serious illness or medical conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.;Secondary Objective: - To assess the safety profile of the combination, - To evaluate other efficacy parameters of the combination: - Progression free survival, - Duration of response, - Time to treatment failure, - Overall survival. ;Primary end point(s): Evaluation of the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.	—

Measure

Time frame

Main Objective: To evaluate the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.;Secondary Objective: - To assess the safety profile of the combination, - To evaluate other efficacy parameters of the combination: - Progression free survival, - Duration of response, - Time to treatment failure, - Overall survival. ;Primary end point(s): Evaluation of the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.

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Countries

Spain

Outcome results

None listed

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