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Completed

NCT Number: NCT01941771

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Drug

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)

Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Drug

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)

Primary outcomes

  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 outcomes

  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 outcomes

  1. Toxicity

    Time frame: Side effects of treatment

    Monitoring side effects of treatment assessed up to 60 months.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Pierre Fabre Laboratories

Registry information

Official study 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.

Acronym: XeNa

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 13, 2013
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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