XERAD: A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Breast Cancer With Newly Diagnosed Brain Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00977379
First received: September 14, 2009
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This open-label, randomized, parallel arm study will evaluate the effect of Xelo da administered concurrently with Whole Brain Radiation Therapy (WBRT) and as ma intenance therapy in patients with breast cancer and newly diagnosed brain metas tases. Patients will be randomized to receive either Xeloda (825 mg/sqm orally b id) on days 1-14 of the 1st 3-week cycle together with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with Xeloda (1000 mg/sqm orally bid

) on days 1-14 from cycle 2 onwards, or another systemic therapy in the WBRT onl y group. The anticipated time on study treatment is until disease progression an d the target sample size is <150.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine [Xeloda]
Drug: systemic therapy
Radiation: WBRT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: XERAD: Open-label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda® ) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Best objective CNS response (CR+PR) assessed by contrast-enhanced MRI reviewed by centralized independent expert [ Time Frame: MRI 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective CNS response (CR+PR) assessed by MRI 4 weeks after completion of WBRT [ Time Frame: 6 weeks after 1st day of radiotherapy ] [ Designated as safety issue: No ]
  • Best objective CNS response (CR+PR), clinical benefit (CR+PR+stable disease), duration of CNS response, brain progression-free survival [ Time Frame: assessed 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter or at time of clinical deterioration ] [ Designated as safety issue: No ]
  • Extracranial disease response rate according to RECIST criteria [ Time Frame: assessed after 6 weeks and every 9 weeks thereafter ] [ Designated as safety issue: No ]
  • progression-free survival (CNS or extracranial), overall survival [ Time Frame: assessed every 9 weeks or at time of clinical deterioration and by the end of the study ] [ Designated as safety issue: No ]
  • Safety, AEs [ Time Frame: throughout study, laboratory and neurological assessments every 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: systemic therapy
at investigator's discretion from 4 weeks after 1st dose of WBRT onward
Radiation: WBRT
3000 cGy in 10 single daily fractions over 12 to 14 days (300cGy/fraction)
Experimental: B Drug: capecitabine [Xeloda]
825 mg/sqm orally bid, days 1-14 of 1st 3-week cycle; 1000 mg/sqm orally bid, days 1-14 from cycle 2 onward
Radiation: WBRT
3000 cGy in 10 single daily fractions over 12 to 14 days (300cGy/fraction)

  Eligibility

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

Inclusion Criteria:

  • women >/= 18 years of age
  • histologically confirmed breast cancer with known HER2 and hormone status
  • newly diagnosed CNS metastasis with at least one measurable (>/=0.5cm) lesion
  • patient not eligible or refusing surgery or stereotactic radiosurgery
  • EOCG performance status 0-2

Exclusion Criteria:

  • prior treatment of brain metastases
  • prior disease progression or appearance of brain metastases while on treatment with capecitabine
  • leptomeningeal disease
  • known contra-indication to radiotherapy or MRI or capecitabine
  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 ClinicalTrials.gov identifier: NCT00977379

Locations
France
Arras, France, 62000
Beuvry, France, 62660
Beziers, France, 34500
Bobigny, France, 93009
Dijon, France, 21079
Le Mans, France, 72015
Lille, France, 59020
Lyon, France, 69373
Montpellier, France, 34928
Nantes, France, 44202
Narbonne, France, 11780
Nice, France, 06000
Paris, France, 75651
Paris, France, 75475
Rouen, France, 76000
Salouel, France, 80480
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00977379     History of Changes
Other Study ID Numbers: ML21873, 2008-007349-30
Study First Received: September 14, 2009
Last Updated: October 13, 2014
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 October 16, 2014