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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977379
• Other study ID #: ML21873
• Secondary ID: 2008-007349-30
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2009
• Last updated: April 2, 2016
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This open-label, randomized, parallel arm study will evaluate the effect of Xeloda administered concurrently with Whole Brain Radiation Therapy (WBRT) and as maintenance therapy in patients with breast cancer and newly diagnosed brain metastases. Patients will be randomized to receive either Xeloda (825 mg/sqm orally bid) 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 only group. The anticipated time on study treatment is until disease progression and the target sample size is <150.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• WBRT
3000 cGy in 10 single daily fractions over 12 to 14 days (300cGy/fraction)

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
• systemic therapy
at investigator's discretion from 4 weeks after 1st dose of WBRT onward

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best objective CNS response (CR+PR) assessed by contrast-enhanced MRI reviewed by centralized independent expert		MRI 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter	No
Secondary	Objective CNS response (CR+PR) assessed by MRI 4 weeks after completion of WBRT		6 weeks after 1st day of radiotherapy	No
Secondary	Best objective CNS response (CR+PR), clinical benefit (CR+PR+stable disease), duration of CNS response, brain progression-free survival		assessed 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter or at time of clinical deterioration	No
Secondary	Extracranial disease response rate according to RECIST criteria		assessed after 6 weeks and every 9 weeks thereafter	No
Secondary	progression-free survival (CNS or extracranial), overall survival		assessed every 9 weeks or at time of clinical deterioration and by the end of the study	No
Secondary	Safety, AEs		throughout study, laboratory and neurological assessments every 3 weeks	No