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Sequential Oral Therapy (SOT trial) in elderly patients with metastatic breast cancer: a phase IV randomized trial - SOT trial

Sequential Oral Therapy (SOT trial) in elderly patients with metastatic breast cancer: a phase IV randomized trial - SOT trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004848-23-IT
Enrollment
Unknown
Registered
2007-06-13
Start date
2006-09-12
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

breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006279 Term: Breast neoplasm

Interventions

Trade Name: NAVELBINE*1CPS 20MG Pharmaceutical Form: Capsule, soft INN or Proposed INN: Vinorelbine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name:

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The english version will follow Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: The english version will follow

Design outcomes

Primary

MeasureTime frame
Main Objective: valutare il tempo alla progressione delle due modalita' di somministrazione della chemioterapia con vinorelbine e capecitabina ;Secondary Objective: valutare il profilo di tollerabilita', il tasso di risposta e la sopravvivenza globale delle due modalita' di somministrazione della chemioterapia con vinorelbine e capecitabina ;Primary end point(s): The english version will follow—

Countries

Italy

Outcome results

None listed

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