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Completed

NCT Number: NCT01077726

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

capecitabine [Xeloda]

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: 4 months

Secondary outcomes

  1. Objective Central Nervous System (CNS) response

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

  2. 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

  3. Cranial PFS

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

  4. Progression-free survival\n

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

  5. Clinical benefit \n

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

  6. Extra-cranial disease response rate\n

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

  7. Overall Survival (OS)\n

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 1, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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