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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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01077726
First received: January 15, 2010
Last updated: November 3, 2014
Last verified: November 2014

January 15, 2010
November 3, 2014
January 2010
December 2010   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01077726 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: From the first administration of study treatment to the time of documented recurrence or progression ] [ Designated as safety issue: No ]
  • Clinical benefit [ Time Frame: From first administration of study treatment to study end (12 Months) ] [ Designated as safety issue: No ]
  • Extra-cranial disease response rate [ 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) [ Time Frame: From first administration of study treatment to the time of death from any cause ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression
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 bra in metastases in breast cancer patients with central nervous system (CNS) progre ssion 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 i s until disease progression, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Experimental: 1
Intervention: Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01077726
ML22203, 2008-007350-35
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP