NCT01777945

Brief Summary

This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

14 active sites

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

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 19, 2016

Completed
Last Updated

August 19, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 25, 2013

Results QC Date

April 12, 2016

Last Update Submit

July 12, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS)

    The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.

    approximately 2 years

Secondary Outcomes (6)

  • Time to Treatment Failure

    approximately 2 years

  • Overall Response Rate

    approximately 2 years

  • Clinical Benefit Rate

    approximately 2 years

  • Duration of Treatment With Xeloda

    approximately 2 years

  • Percentage of Capecitabine Dose Modifications

    approximately 2 years

  • +1 more secondary outcomes

Study Arms (1)

Participants Receiving Capecitabine/Docetaxel

Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.

Drug: capecitabineDrug: docetaxel

Interventions

capecitabineDRUG

Participants received capecitabine according to individualized physician-prescribed regimen.

Participants Receiving Capecitabine/Docetaxel
docetaxelDRUG

Participants received docetaxel according to individualized physician-prescribed regimens.

Participants Receiving Capecitabine/Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel

You may qualify if:

  • Adult participants, \>/= 18 years of age
  • HER2-negative metastatic breast cancer
  • Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

You may not qualify if:

  • Contraindications to Xeloda treatment according to the Summary of Product Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Budapest, 1067, Hungary

Location

Unknown Facility

Budapest, 1122, Hungary

Location

Unknown Facility

Budapest, 1125, Hungary

Location

Unknown Facility

Budapest, 1145, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Gyula, 5700, Hungary

Location

Unknown Facility

Kaposvár, 7400, Hungary

Location

Unknown Facility

Kecskemét, 6000, Hungary

Location

Unknown Facility

Miskolc, 3501, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Szeged, 6720, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Veszprém, 8200, Hungary

Location

Unknown Facility

Zalaegerszeg, 8900, Hungary

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CapecitabineDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
1-800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 19, 2016

Results First Posted

August 19, 2016

Record last verified: 2016-02

Locations

HU(14)