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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01077726
First received: January 15, 2010
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: capecitabine [Xeloda]
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Central Nervous System (CNS) response [ Time Frame: From first administration of study treatment until documented CNS recurrence or progression ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cranial PFS [ Time Frame: From the first administration of study treatment to the time of documented cranial recurrence or progression\n ] [ Designated as safety issue: No ]
  • Progression-free survival\n [ Time Frame: From the first administration of study treatment to the time of documented recurrence or progression\n ] [ Designated as safety issue: No ]
  • Clinical benefit \n [ Time Frame: From first administration of study treatment to study end (12 Months) ] [ Designated as safety issue: No ]
  • Extra-cranial disease response rate\n [ Time Frame: From first administration of study treatment to the time of documented extra-cranial recurrence or progression ] [ Designated as safety issue: No ]
  • Overall Survival (OS)\n [ Time Frame: From first administration of study treatment to the time of death from any cause ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: January 2010
Study Completion Date: April 2011
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077726

Locations
France
Angers, France, 49933
Arras, France, 62000
Beziers, France, 34500
Bobigny, France, 93009
Caen, France, 14076
Lille, France, 59020
Lyon, France, 69008
Narbonne, France, 11780
Nice, France, 06000
Paris, France, 75651
Paris, France, 75475
Salouel, France, 80480
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01077726     History of Changes
Other Study ID Numbers: ML22203, 2008-007350-35
Study First Received: January 15, 2010
Last Updated: January 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013