NCT01077726

Brief Summary

This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

12 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

January 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

January 15, 2010

Last Update Submit

November 1, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    4 months

Secondary Outcomes (7)

  • Objective Central Nervous System (CNS) response

    From first administration of study treatment until documented CNS recurrence or progression

  • Duration of CNS response

    From time of first documented cranial complete response (CR) or partial response (PR) (whichever is recorded first) until the first date CNS recurrence or progression is documented

  • Cranial PFS

    From the first administration of study treatment to the time of documented cranial recurrence or progression\n

  • Progression-free survival\n

    From the first administration of study treatment to the time of documented recurrence or progression\n

  • Clinical benefit \n

    From first administration of study treatment to study end (12 Months)

  • +2 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: capecitabine [Xeloda]

Interventions

capecitabine [Xeloda]DRUG

1000mg/m2 po bid on days 1-14 of each 3 week cycle

1

Eligibility Criteria

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

You may qualify if:

  • female patients, \>=18 years of age;
  • breast cancer;
  • CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
  • at least one measurable lesion;
  • ECOG performance status 0-2.

You may not qualify if:

  • prior systemic treatment of brain metastases;
  • prior disease progression while on Xeloda treatment;
  • previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
  • clinically significant cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Angers, 49055, France

Location

Unknown Facility

Arras, 62000, France

Location

Unknown Facility

Béziers, 34500, France

Location

Unknown Facility

Bobigny, 93009, France

Location

Unknown Facility

Caen, 14076, France

Location

Unknown Facility

Lille, 59020, France

Location

Unknown Facility

Lyon, 69373, France

Location

Unknown Facility

Narbonne, 11780, France

Location

Unknown Facility

Nice, 06000, France

Location

Unknown Facility

Paris, 75475, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Salouël, 80480, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

March 1, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(12)