RANDOMIZED CLINICAL TRIAL TO COMPARE THE BENEFIT OF ADDING HERCEPTIN TO CAPECITABINE PLUS VINORELBINE AS SECOND LINE TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED NON OPERABLE OR METASTATIC BREAST CANCER WITH OVEREXPRESSION OF HER-2, WHO HAVE PROGRESSED TO A PREVIOUS LINE OF TREATMENT FOR METASTATIC DISEASE WITH TRASTUZUMAB IN COMBINATION WITH TAXANES

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000405-56-ES

Enrollment

Registered

2006-05-16

Start date

2005-06-01

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

PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER AND OVEREXPRESSION OF HER2.

Interventions

Trade Name: NAVELBINE Product Name: NAVELBINE Pharmaceutical Form: Solution for injection INN or Proposed INN: VINORELBINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must sign an informed consent before of specific procedures of clinical trial. Patients with histologically confirmed breast cancer and overexpression of HER2. Age > 18 years. Patients with locally advanced non operable or mestatatic breast cancer previously treated with a regimen of chemotherapy that included trastuzumab and taxanes. Clinical measurable or not measurable disease defined by the RECIST criteria. Women of childbearing potential must have a negative pregnancy test (serum or urine beta HCG) within 14 days prior to initiation of chemotherapy. Patients should have adequate organ function to tolerate chemotherapy. ECOG equal or =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with hypersensitivity reactions to any of the medications of the clinical trial. Patients who are pregnant or lactating are not eligible. Active infection or a concomitant serious disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of the treatment in terms of clinical benefit rate.;Secondary Objective: To evaluate time to progression To evaluate objective response Rate To evaluate the profile of toxicity Overall survival Quality of life;Primary end point(s): Clinical benefit will be based on the percentage of patients who had experienced a total o partial response or an estabilization of the disease for a period of time of at least 24 weeks.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of the treatment in terms of clinical benefit rate.;Secondary Objective: To evaluate time to progression To evaluate objective response Rate To evaluate the profile of toxicity Overall survival Quality of life;Primary end point(s): Clinical benefit will be based on the percentage of patients who had experienced a total o partial response or an estabilization of the disease for a period of time of at least 24 weeks.

—

Countries

Spain

Outcome results

None listed

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