Faslodex 500mg Multiple Dose Tolerability Study in BC Pat... | NCT00328120

Studies
Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

NCT00328120

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 17, 2010Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Advanced Breast Cancer

Interventions

Fulvestrant

Countries

Japan

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
9238IL/0062

Status Module

Record Verification Date

Nov 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

Apr 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Jun 2010Actual

First Submitted Date

May 18, 2006

First Submission Date that Met QC Criteria

May 18, 2006

First Posted Date

May 19, 2006Estimated

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

Nov 16, 2010

Last Update Posted Date

Nov 17, 2010Estimated

Description Module

Brief Summary

The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent 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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
Fulvestrant	Drug	500 mg intramuscular injection		Faslodex ZD9238

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is to assess the tolerability of 500mg fulvestrant		assessed when all patients have been in the study for 6 months

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics		each visit
Time to progression		assessed when all patients have been in the study for 6 months
ORR

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of written informed consent
Postmenopausal woman who fulfils any one of the following criteria:
Histological or cytological confirmation of breast cancer
Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion Criteria:

Having received any one of the following therapy for advanced or recurrent breast cancer
2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Breast Cancer Established Brands Team Medical Science Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Chiba			Japan
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
D000077267	Fulvestrant

Ancestor Terms

ID	Term
D004958	Estradiol
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided