NCT01215123

Brief Summary

This observational study will assess the median time of treatment duration and the safety of Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data will be collected for approximately 24 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

September 27, 2010

Results QC Date

January 25, 2016

Last Update Submit

January 25, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to Disease Progression (TDP)

    Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Up to a maximum of 36.4 months

Secondary Outcomes (1)

  • Treatment Duration: Number of Bevacizumab Cycles

    Up to a maximum of 36.4 months

Study Arms (1)

Bevacizumab

Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.

Drug: Bevacizumab

Interventions

BevacizumabDRUG

Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.

Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Breast cancer patients with first line treatment with Avastin

You may qualify if:

  • Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin

You may not qualify if:

  • Patients not willing or unable to signed written consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Buenos Aires, B1708EIL, Argentina

Location

Unknown Facility

Buenos Aires, C1113AAC, Argentina

Location

Unknown Facility

Buenos Aires, C1116ABC, Argentina

Location

Unknown Facility

Buenos Aires, C1199ACI, Argentina

Location

Unknown Facility

Buenos Aires, C1414CEF, Argentina

Location

Unknown Facility

Buenos Aires, C1417DTB, Argentina

Location

Unknown Facility

Buenos Aires, C1426ANZ, Argentina

Location

Unknown Facility

Capital Federal, C1426ALV, Argentina

Location

Unknown Facility

La Pampa, 6300, Argentina

Location

Unknown Facility

Mar del Plata, 7600, Argentina

Location

Unknown Facility

Rosario, S2000DSK, Argentina

Location

Unknown Facility

San Miguel de Tucumán, T4000IAK, Argentina

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 27, 2010

First Posted

October 6, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 22, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations

AR(12)