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

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.

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda); Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C
    • Aarhus, Aarhus C, Denmark, 8000
      • Department of Oncology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; 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.	Drug: 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.; Other Names: Vinorelbine (Navelbine oral); Capecitabine (Xeloda); Other Names:
Experimental: Arm B; 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.	Drug: 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.; Other Names: Vinorelbine (Navelbine oral); Capecitabine (Xeloda)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint is overall response rate i both arms.	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.	up to 60 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression.	Number of days from start of treatment to progression of disease assessed up to 60 months	up to 60 month
Overall survival.	Number of days from start of treatment to death assessed up to 60 months.	up to 60 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Monitoring side effects of treatment assessed up to 60 months.	Side effects of treatment

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Pierre Fabre Laboratories
• Investigators: Principal Investigator: Sven Tyge Langkjer, MD, PhD, University Hospital of Aarhus

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Capecitabine; Breast cancer; Metronomic chemotherapy; Vinorelbine; Navelbine; Xeloda; Antineoplastic Agents
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Capecitabine; Vinorelbine
• Other Study ID Numbers: EUDRACT nr. 2011-003564-72; 2011-003564-72 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No