An Observational Study of Avastin (Bevacizumab) in Combin... | NCT01661153

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

NCT01661153

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Aug 25, 2017Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2011Actual

Primary Completion Date

Sep 14, 2016Actual

Completion Date

Sep 14, 2016Actual

First Submitted Date

Aug 7, 2012

First Submission Date that Met QC Criteria

Aug 7, 2012

First Posted Date

Aug 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2017

Last Update Posted Date

Aug 25, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival		approximately 2.5 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uni Hospital Split; Oncology & Radiotherapy		Split		21000	Croatia
General Hospital Varazdin

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided