A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression

November 1, 2016 updated by: Hoffmann-La Roche

A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49055
      • Arras, France, 62000
      • Beziers, France, 34500
      • Bobigny, France, 93009
      • Caen, France, 14076
      • Lille, France, 59020
      • Lyon, France, 69373
      • Narbonne, France, 11780
      • Nice, France, 06000
      • Paris, France, 75651
      • Paris, France, 75475
      • Salouel, France, 80480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Central Nervous System (CNS) response
Time Frame: From first administration of study treatment until documented CNS recurrence or progression
From first administration of study treatment until documented CNS recurrence or progression
Duration of CNS response
Time Frame: 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
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
Time Frame: From the first administration of study treatment to the time of documented cranial recurrence or progression\n
From the first administration of study treatment to the time of documented cranial recurrence or progression\n
Progression-free survival\n
Time Frame: From the first administration of study treatment to the time of documented recurrence or progression\n
From the first administration of study treatment to the time of documented recurrence or progression\n
Clinical benefit \n
Time Frame: From first administration of study treatment to study end (12 Months)
From first administration of study treatment to study end (12 Months)
Extra-cranial disease response rate\n
Time Frame: From first administration of study treatment to the time of documented extra-cranial recurrence or progression
From first administration of study treatment to the time of documented extra-cranial recurrence or progression
Overall Survival (OS)\n
Time Frame: From first administration of study treatment to the time of death from any cause
From first administration of study treatment to the time of death from any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22203
  • 2008-007350-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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