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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

Page last updated: August 23, 2015

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