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Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca

NCT02144194 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-02-09

No results posted yet for this study

Summary

This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.

Conditions

Interventions

DRUG

Vinorelbine-Docetaxel

Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles

DRUG

Vinorelbine

Oral Vinorelbine 60mg/m2 or 80mg/m2 D1, D8 every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue (dose schedule is at investigator's discretion)

Sponsors & Collaborators

  • Cancer Research Group - Collaborative Group, Beirut, Lebanon.

    lead OTHER

Principal Investigators

  • Fadi Farhat, M.D · Hammoud Hospital University Medical Center

  • Marwan Ghosn, M.D · Hotel Dieu De France University Hospital

  • Georges Chahine, M.D · Hotel Dieu de France University Hospital

  • Joseph Kattan, M.D · Hotel Dieu de France University Hospital

  • Nizar Bitar, M.D · Sahel General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • Lebanon

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144194 on ClinicalTrials.gov