NCT01941771

Brief Summary

The study hypothesis is that metronomic treatment is more efficient than standard treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

September 5, 2012

Last Update Submit

October 27, 2016

Conditions

Breast Cancer

Keywords

Breast cancerMetronomic chemotherapyVinorelbineNavelbineCapecitabineXelodaAntineoplastic Agents

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint is overall response rate i both arms.

    Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated.

    up to 60 month

Secondary Outcomes (2)

  • Time to progression.

    up to 60 month

  • Overall survival.

    up to 60 month

Other Outcomes (1)

  • Toxicity

    Side effects of treatment

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Arm B

EXPERIMENTAL

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Interventions

Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)DRUG

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Also known as: Vinorelbine (Navelbine oral), Capecitabine (Xeloda)
Arm B
Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)DRUG

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Also known as: Other Names:, Vinorelbine (Navelbine oral), Capecitabine (Xeloda)
Arm A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
  • WHO performance status \< 3

You may not qualify if:

  • Former treatment with Capecitabine or Vinorelbine
  • Patients who have received more than one line of chemotherapy for metastatic disease
  • Brain metastases
  • Malabsorption syndrome
  • Abnormal organ function
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

VinorelbineCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Sven Tyge Langkjer, MD, PhD

    University hospital of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant, MD, ph.d.

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 13, 2013

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

DK(1)