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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 13, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

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 ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 60 months ]
  • Safety: Incidence of adverse events [ Time Frame: 60 months ]

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)


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

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
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Please refer to this study by its identifier: NCT01277133

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01277133     History of Changes
Other Study ID Numbers: ML25191
Study First Received: January 13, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on May 25, 2017