A Study of Patients With HER2-Positive Metastatic Breast... | NCT00105456

Studies
A Study of Patients With HER2-Positive Metastatic Breast Cancer

NCT00105456

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

May 6, 2010Estimated

Enrollment

1,000

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

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

May 2010

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 2003

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Mar 14, 2005

First Submission Date that Met QC Criteria

Mar 14, 2005

First Posted Date

Mar 15, 2005Estimated

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

May 4, 2010

Last Update Posted Date

May 6, 2010Estimated

Description Module

Brief Summary

This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.

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

1,000

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed Informed Consent document (unless the IRB has granted a waiver of consent)
Signed Authorization for the Use and Disclosure of Health Information document
HER2-positive breast cancer
Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

There are no exclusion criteria for participation in this trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients from managed care organizations, community physicians or practices, and academic centers.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Isaiah Dimery, M.D.	Genentech, Inc.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24743708	Derived	Yardley DA, Tripathy D, Brufsky AM, Rugo HS, Kaufman PA, Mayer M, Magidson J, Yoo B, Quah C, Ulcickas Yood M. Long-term survivor characteristics in HER2-positive metastatic breast cancer from registHER. Br J Cancer. 2014 May 27;110(11):2756-64. doi: 10.1038/bjc.2014.174. Epub 2014 Apr 17.

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