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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine [Xeloda]

• Registration Number: NCT01077726
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	capecitabine [Xeloda]	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	4 months

Secondary Outcome Measures

Name	Time	Method
Objective Central Nervous System (CNS) response	From first administration of study treatment until documented CNS recurrence or progression
Progression-free survival\n	From the first administration of study treatment to the time of documented recurrence or progression\n
Cranial PFS	From the first administration of study treatment to the time of documented cranial recurrence or progression\n
Clinical benefit \n	From first administration of study treatment to study end (12 Months)
Duration of CNS response	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
Extra-cranial disease response rate\n	From first administration of study treatment to the time of documented extra-cranial recurrence or progression
Overall Survival (OS)\n	From first administration of study treatment to the time of death from any cause