A comparison of Navelbine given as daily treatment or treatment on day 1 and 8 every 3 weeks in patients with advanced breast cancer

The NAME-trial: A direct comparison of oral Navelbine given either as classical or metronomic therapy in metastatic breast cancer - The NAME-trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002165-63-NO

Enrollment

200

Registered

2018-05-15

Start date

2018-09-28

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

BREAST CANCER MedDRA version: 20.1 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Breast cancer patients with metastatic disease (HER-2 negative) 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: Previous therapy with Navelbine

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of an experimental chemotherapy arm where Navelbine is given daily (small doses) to a standard treatment arm of Navelbine given on day 1 and 8 every 3 weeks (established standard therapy);Secondary Objective: To study the side effects of both treatment arms;;Primary end point(s): PRIMARY OBJECTIVE: to compare the disease contol rate defined as CR-PR+SD (>3 months) of the two treatment arms;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 (small doses) to a standard treatment arm of Navelbine given on day 1 and 8 every 3 weeks (established standard therapy);Secondary Objective: To study the side effects of both treatment arms;;Primary end point(s): PRIMARY OBJECTIVE: to compare the disease contol rate defined as CR-PR+SD (>3 months) of the two treatment arms;Timepoint(s) of evaluation of this end point: At the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): Comparing the side-effects of the two treatment arms; Comparing time to progression (TTP); Comparing response rates (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	—

Countries

Denmark, Norway

Contacts

Public ContactPRINCIPAL INVESTIGATOR NORWAY

AKERSHUS UNIVERSITY HOSPITAL

juergen.geisler@medisin.uio.no4791187447

Outcome results

None listed

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