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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077726
• Other study ID #: ML22203
• Secondary ID: 2008-007350-35
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: November 1, 2016
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle

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	Progression-free survival		4 months	No
Secondary	Objective Central Nervous System (CNS) response		From first administration of study treatment until documented CNS recurrence or progression	No
Secondary	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	No
Secondary	Cranial PFS		From the first administration of study treatment to the time of documented cranial recurrence or progression\n	No
Secondary	Progression-free survival\n		From the first administration of study treatment to the time of documented recurrence or progression\n	No
Secondary	Clinical benefit \n		From first administration of study treatment to study end (12 Months)	No
Secondary	Extra-cranial disease response rate\n		From first administration of study treatment to the time of documented extra-cranial recurrence or progression	No
Secondary	Overall Survival (OS)\n		From first administration of study treatment to the time of death from any cause	No