Study on Pre-menopausal Patients With Advanced ER and PR... | NCT00235937

Studies
Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex

NCT00235937

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 21, 2011Estimated

Enrollment

45Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Anastrozole and goserelin

Countries

France

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

ID	Type	Description	Link
THR 0104233 C

Status Module

Record Verification Date

Jan 2011

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

Dec 2001

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Oct 10, 2005

First Submission Date that Met QC Criteria

Oct 10, 2005

First Posted Date

Oct 12, 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

Jan 20, 2011

Last Update Posted Date

Jan 21, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
Anastrozole and goserelin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the feasibility and efficacy of the combination of these 2 drugs in these patients

Secondary Outcomes

Measure	Description	Time Frame
To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters.

Exclusion Criteria:

Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
AstraZeneca France Medical Director, MD	AstraZeneca	Study Director

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

Intervention Browse Module

MeSH Terms

ID	Term
D000077384	Anastrozole
D017273	Goserelin

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Angers			France