An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661153
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This prospective observational study will evaluate the use in clinical practice, efficacy and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up to 2.5 years.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer
Actual Study Start Date : March 2, 2011
Actual Primary Completion Date : September 14, 2016
Actual Study Completion Date : September 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources


Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: approximately 2.5 years ]

Secondary Outcome Measures :
  1. Dosage/schedule/number of cycles of Avastin treatment in clinical practice [ Time Frame: approximately 2.5 years ]
  2. Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ]

Information from the National Library of Medicine

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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
HER2-negative breast cancer patients in first-line treatment of metastatic disease

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally recurrent or metastatic breast cancer
  • No prior treatment for metastatic or locally recurrent disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • History or clinical evidence of brain metastases
  • Pregnancy
  • Uncontrolled hypertension ( systolic > 150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to enrolment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661153

Uni Hospital Split; Oncology & Radiotherapy
Split, Croatia, 21000
General Hospital Varazdin
Varazdin, Croatia, 42000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01661153     History of Changes
Other Study ID Numbers: ML25312
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors