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

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ClinicalTrials.gov Identifier: NCT01941771
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Pierre Fabre Laboratories
Information provided by (Responsible Party):
Sven Langkjer, University of Aarhus

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) Phase 2

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  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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:
  • Other Names:
  • Vinorelbine (Navelbine oral)
  • Capecitabine (Xeloda)

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)




Primary Outcome Measures :
  1. Primary endpoint is overall response rate i both arms. [ Time Frame: 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 :
  1. Time to progression. [ Time Frame: up to 60 month ]
    Number of days from start of treatment to progression of disease assessed up to 60 months

  2. Overall survival. [ Time Frame: up to 60 month ]
    Number of days from start of treatment to death assessed up to 60 months.


Other Outcome Measures:
  1. Toxicity [ Time Frame: Side effects of treatment ]
    Monitoring side effects of treatment assessed up to 60 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941771


Locations
Denmark
Department of Oncology, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Pierre Fabre Laboratories
Investigators
Principal Investigator: Sven Tyge Langkjer, MD, PhD University hospital of Aarhus

Responsible Party: Sven Langkjer, consultant, MD, ph.d., University of Aarhus
ClinicalTrials.gov Identifier: NCT01941771     History of Changes
Other Study ID Numbers: EUDRACT nr. 2011-003564-72
2011-003564-72 ( EudraCT Number )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Keywords provided by Sven Langkjer, University of Aarhus:
Breast cancer
Metronomic chemotherapy
Vinorelbine
Navelbine
Capecitabine
Xeloda
Antineoplastic Agents

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Vinorelbine
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators