Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) (Drug); Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Sven Tyge Langkjer, MD, PhD, Principal Investigator, Affiliation: University hospital of Aarhus
Summary
The study hypothesis is that metronomic treatment is more efficient than standard treatment.
Clinical Details
Official title: Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Primary endpoint is overall response rate i both arms.
Secondary outcome: Time to progression.Overall survival.
Detailed description:
Purpose: In an open-label randomized phase II trial, patients with metastatic Human
Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant
WHO performance status < 3 are randomized to receive either capecitabine (day 1-14) plus
vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic
(3 days a week).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative
breast cancer
- WHO performance status < 3
Exclusion Criteria:
- Former treatment with Capecitabine or Vinorelbine
- Patients who have received more than one line of chemotherapy for metastatic disease
- Brain metastases
- Malabsorption syndrome
- Abnormal organ function
- pregnant or lactating women
Locations and Contacts
Department of Oncology, Aarhus University Hospital, Aarhus, Aarhus C 8000, Denmark; Recruiting Sven Tyge Langkjer, MD, ph.d., Phone: +45 7846 9721, Email: svenlang@rm.dk Charlotte B Jensen, study nurse, Phone: +45 7846 4440, Email: chajense@rm.dk Sven T Langkjer, MD, ph.d., Principal Investigator
Additional Information
Starting date: June 2012
Last updated: December 2, 2014
|