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

Breast Cancer Clinical Trial

— XeNa  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941771
• Other study ID #: EUDRACT nr. 2011-003564-72
• Secondary ID: 2011-003564-72
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2012
• Last updated: October 27, 2016
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Pierre Fabre Laboratories

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity	Monitoring side effects of treatment assessed up to 60 months.	Side effects of treatment	Yes
Primary	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	No
Secondary	Time to progression.	Number of days from start of treatment to progression of disease assessed up to 60 months	up to 60 month	No
Secondary	Overall survival.	Number of days from start of treatment to death assessed up to 60 months.	up to 60 month	No