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

Study Overview
=================
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).

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.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
* Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>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)<br>* 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.<br>* Other names: Capecitabine (Xeloda);|
| Experimental: Arm B<br>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)<br>* 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.<br>* Other names: 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Metronomic chemotherapy, Vinorelbine, Navelbine, Capecitabine, Xeloda, Antineoplastic Agents