An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Metastatic Breast Cancer (CRONOS 2)

Breast Cancer Clinical Trial

Official title:

The Correlation Between the Moment of Bevacizumab theRapy initiatiOn and the Efficacy in patieNt With Metastatic Breast Cancer Treated With First Line Regimens Based On AvaStin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01277133
• Other study ID #: ML25191
• Status: Terminated
• Phase: N/A
• First received: January 13, 2011
• Last updated: November 1, 2016
• Start date: June 2010
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic breast cancer. Patients will be followed for up to 12 months after progressive disease occurs.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Previously untreated metastatic breast cancer

• Scheduled to start 1st line chemotherapeutic treatment

• ECOG performance status 0-1

Exclusion Criteria:

• Any conditions included in contraindication list for Avastin

• Prior chemotherapy for metastatic breast cancer

• Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic malignancy completed <6 months prior to treatment start

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the time from start of chemotherapy to the start of Avastin treatment with progression-free survival		60 months	No
Secondary	Overall survival		60 months	No
Secondary	Safety: Incidence of adverse events		60 months	No