NCT01661153

Completed

An Observational Study of Avastin (Bevacizumab) in Combinati...

Hoffmann-La Roche Source

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Other study identifiers

Sponsor study identifier

ML25312

Study Type

observational

Actual enrollment (reported)

16

Locations

1 country

Sites

2

Timeline

Study Start

March 2, 2011

Actual (reported)

Primary Completion

September 14, 2016

Actual (reported)

Study Completion

September 14, 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 16 participants
Study completion date: September 14, 2016
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2, 2011
Actual (reported)
First Submitted
August 7, 2012
Actual (reported)
First Posted
August 9, 2012
Actual (reported)
Primary Completion
September 14, 2016
Actual (reported)
Study Completion
September 14, 2016
Actual (reported)

Last Updated: August 25, 2017
Status Verified: August 2017
Last Update Submitted: August 24, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

Progression-free survival
approximately 2.5 years

Secondary Outcomes (2)

Dosage/schedule/number of cycles of Avastin treatment in clinical practice
approximately 2.5 years
Safety: Incidence of adverse events
approximately 2.5 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

Adult patients, \>/= 18 years of age

Sponsors & Collaborators

Hoffmann-La Roche
Industrylead

Study Sites (2)

Uni Hospital Split; Oncology & Radiotherapy

Split, 21000, Croatia

General Hospital Varazdin

Varaždin, 42000, Croatia

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Clinical Trials
Hoffmann-La Roche
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

March 2, 2011

Actual (reported)

NCT01777932

AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

Completed

NCT00774241

PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

Phase 4Withdrawn

NCT01277133

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)

Terminated

NCT00846027

A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

Phase 2Completed

NCT01094184

A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer

Phase 4Completed

NCT00929240

A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

Phase 3Completed

Locally recurrent or metastatic breast cancer

No prior treatment for metastatic or locally recurrent disease

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

September 14, 2016

Actual (reported)

Study Completion

September 14, 2016

Actual (reported)

Last Updated

August 25, 2017

Record last verified: 2017-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01661153
Data provider: ClinicalTrials.gov
Source updated: 2017-08-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:24 UTC

Locations

HR(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Cohort

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations