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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 15, 2010
Last updated: November 1, 2016
Last verified: November 2016
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:

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: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01077726

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, 75475
Paris, France, 75651
Salouel, France, 80480
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01077726     History of Changes
Other Study ID Numbers: ML22203  2008-007350-35 
Study First Received: January 15, 2010
Last Updated: November 1, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on December 08, 2016