A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis (XERAD)

Roche

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: WBRT; Drug: Standard of Care; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977379

ML21873

2008-007349-30

Details and patient eligibility

About

This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with histologically confirmed breast cancer with known human epidermal receptor-2 (HER2) and hormone status
• Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than or equal to (>/=) 1 centimeter (cm) or two lesions measuring >/= 0.5 to less than (<) 1 cm in longest dimension
• Participant not eligible for or refusing surgery or stereotactic radiosurgery
• Eastern cooperative oncology group (EOCG) performance status 0 to 2

Exclusion criteria

• Prior treatment of brain metastases
• Leptomeningeal disease
• Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or capecitabine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

WBRT Followed by Standard of Care

Active Comparator group

Description:

Participants will receive 3000 centi-Gray (cGy) WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants will be followed during the treatment until the halting of standard of care for any reason (central nervous system \[CNS\] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).

Treatment:

Drug: Standard of Care

Radiation: WBRT

WBRT+Capecitabine Followed by Capecitabine Maintenance

Experimental group

Description:

Participants will receive 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m\^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).

Treatment:

Drug: Capecitabine

Radiation: WBRT