A direct comparison of Oral Navelbine given either classic or metronomic in metastatic breast cancer

A direct comparison of Oral Navelbine given either classic or metronomic in metastatic breast cancer - The NaMe trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002165-63-DK

Enrollment

200

Registered

2017-04-05

Start date

2017-06-06

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Breastcancer MedDRA version: 20.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Navelbine Product Name: Navelbine Product Code: L01CA Pharmaceutical Form: Capsule, soft INN or Proposed INN: VINORELBINE CAS Number: 71486-22-1 Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient with HER 2 negative metastatic breastcancer 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: Earlier treatment with Navelbine

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of an experimental chemotherapy arm, where Navelbine is given daily to a standard treatment arm of either Navelbine day 1 and 8/ 3 weeks or Navelbine day 1, day 8 and day 15/3 weeks.;Secondary Objective: study effect and side effects in the two arms.;Primary end point(s): Primary objectives: Comparing the disease control rate defined as CR+PR+ SD, (SD > 3 months) ;Timepoint(s) of evaluation of this end point: At the end of the study	—

Measure

Time frame

Main Objective: To compare the effect of an experimental chemotherapy arm, where Navelbine is given daily to a standard treatment arm of either Navelbine day 1 and 8/ 3 weeks or Navelbine day 1, day 8 and day 15/3 weeks.;Secondary Objective: study effect and side effects in the two arms.;Primary end point(s): Primary objectives: Comparing the disease control rate defined as CR+PR+ SD, (SD > 3 months) ;Timepoint(s) of evaluation of this end point: At the end of the study

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Objectives: Comparing the side effects (toxicity and feasibility, adverse events grade 2-5 (CTC)) when Navelbine is given either as a small daily dose (metronomic treatment) or with higher doses days 1 and 8, every 3 weeks (conventional treatment). Comparing time to progression (TTP) for the two regimens. Comparing the response rate (RR) Comparing time to treatment failure (TTF) Comparing duration of response (DR) Comparing overall survival (OS) ;Timepoint(s) of evaluation of this end point: at the end of the study	—

Measure

Time frame

Secondary end point(s): Secondary Objectives: Comparing the side effects (toxicity and feasibility, adverse events grade 2-5 (CTC)) when Navelbine is given either as a small daily dose (metronomic treatment) or with higher doses days 1 and 8, every 3 weeks (conventional treatment). Comparing time to progression (TTP) for the two regimens. Comparing the response rate (RR) Comparing time to treatment failure (TTF) Comparing duration of response (DR) Comparing overall survival (OS) ;Timepoint(s) of evaluation of this end point: at the end of the study

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Countries

Denmark

Contacts

Public ContactSven Tyge Langkjer

Aarhus University Hospital, Kræftafdelingen

004578464440

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 9, 2026