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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)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01277133
First received: January 13, 2011
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation between the time from start of chemotherapy to the start of Avastin treatment with progression-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: June 2010
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients with metastatic HER2 negative breast cancer. First-line treatment with Avastin
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277133

Locations
Romania
Cluj Napoca, Romania, 400015
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01277133     History of Changes
Other Study ID Numbers: ML25191 
Study First Received: January 13, 2011
Last Updated: September 1, 2016
Health Authority: Romania: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 27, 2016