Observational Triveneto Study on the Use of Adjuvant Horm... | NCT00884143

Studies
Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer

NCT00884143

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 20, 2010Estimated

Enrollment

515Actual

Phase

Not provided

Conditions

Post Menopausal
Breast Cancer

Interventions

Not provided

Countries

Italy

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

Apr 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

Jul 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Apr 17, 2009

First Submission Date that Met QC Criteria

Apr 17, 2009

First Posted Date

Apr 20, 2009Estimated

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

Apr 19, 2010

Last Update Posted Date

Apr 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There are different types of hormonal therapy medicines for the treatment of hormone-receptor-positive breast cancer. The purpose of this study is to determine the evolution of two types of hormonal treatment (the drug called "tamoxifen" and a group of medicines called "aromatase inhibitors") during two time periods of 12 months each, in years 2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of implementation of the updated national and international recommendations for the use of adjuvant hormonal therapy in the hormone-receptor-positive 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

515Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative frequencies of the first adjuvant hormonal treatment (tamoxifen vs aromatase inhibitor) started during two time periods of 12 months each - the years 2006 and 2008		May-July 2009

Secondary Outcomes

Measure	Description	Time Frame
Relative frequencies of the type of initial treatment: upfront (a single drug - tamoxifen or aromatase inhibitor) or early switch (planned sequence of tamoxifen and inhibitor)		May-July 2009
Type of treatment and relative percentages of treatment undertaken by the patients after interruption of the first hormonal therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy between January 2006 and December 2006 or between January 2008 and December 2008
Documented evidence of the way adjuvant hormonal treatment was initiated.

Exclusion Criteria:

Pre- or peri-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy
Patients already enrolled in clinical studies aimed at investigating hormone therapies

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Post-menopausal patients with breast cancer already treated with advjuvant hormonal therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Davide Meani, Dr.	AstraZeneca S. p. A.	Study Chair
Raffaele Sabia	AstraZeneca S.p.A	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aviano	PN		Italy
Research Site

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