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

Hoffmann-La Roche3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

capecitabine [Xeloda]DRUG

1000mg/m2 po bid on days 1-14 of each 3 week cycle

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Unnamed facility

Angers, France

Unnamed facility

Arras, France

Unnamed facility

Béziers, France

Unnamed facility

Bobigny, France

Outcomes

Primary Outcomes

Progression-free survival

Time frame: 4 months

Secondary Outcomes

Objective Central Nervous System (CNS) response

Time frame: From first administration of study treatment until documented CNS recurrence or progression

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

Cranial PFS

Time frame: From the first administration of study treatment to the time of documented cranial recurrence or progression\n

Progression-free survival\n

Time frame: From the first administration of study treatment to the time of documented recurrence or progression\n

Clinical benefit \n

Time frame: From first administration of study treatment to study end (12 Months)

Extra-cranial disease response rate\n

Time frame: From first administration of study treatment to the time of documented extra-cranial recurrence or progression

Overall Survival (OS)\n

Time frame: From first administration of study treatment to the time of death from any cause

Data from ClinicalTrials.gov

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