Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda); Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

• Registration Number: NCT01941771
• Lead Sponsor: University of Aarhus

Brief Summary

The study hypothesis is that metronomic treatment is more efficient than standard treatment.

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).

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
• WHO performance status < 3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)	Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.
Arm B	Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)	Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Primary Outcome Measures

Name	Time	Method
Primary endpoint is overall response rate i both arms.	up to 60 month	Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated.

Secondary Outcome Measures

Name	Time	Method
Time to progression.	up to 60 month	Number of days from start of treatment to progression of disease assessed up to 60 months
Overall survival.	up to 60 month	Number of days from start of treatment to death assessed up to 60 months.

Trial Locations

Locations (1)

Department of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus C, Denmark