Clinical trial NCT01077726: A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 4 months
Secondary outcomes:
measure: Objective Central Nervous System (CNS) response
timeFrame: From first administration of study treatment until documented CNS recurrence or progression
measure: Duration of CNS response
timeFrame: 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
measure: Cranial PFS
timeFrame: From the first administration of study treatment to the time of documented cranial recurrence or progression\n
measure: Progression-free survival\n
timeFrame: From the first administration of study treatment to the time of documented recurrence or progression\n
measure: Clinical benefit \n
timeFrame: From first administration of study treatment to study end (12 Months)
measure: Extra-cranial disease response rate\n
timeFrame: From first administration of study treatment to the time of documented extra-cranial recurrence or progression
measure: Overall Survival (OS)\n
timeFrame: From first administration of study treatment to the time of death from any cause
Other outcomes:
Locations:
city: Angers
country: France
city: Arras
country: France
city: Beziers
country: France
city: Bobigny
country: France
city: Caen
country: France
city: Lille
country: France
city: Lyon
country: France
city: Narbonne
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Salouel
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: