Steroid Aromatase Inhibitors Versus Progestogens for nSAI... | NCT02161315

Studies
Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer

NCT02161315

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Dec 22, 2015Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Carcinoma Breast Stage IV

Interventions

Not provided

Countries

China

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

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Nov 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jan 6, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 11, 2014Estimated

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

Dec 21, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.

Detailed Description

A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation group		Steroid Aromatase Inhibitors
Control group		Non-Steroid Aromatase Inhibitor

Interventions

Not provided

Measure	Description	Time Frame
RECIST 1.1		-7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be the postmenopausal women
Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology
Immunohistochemistry shows ER and/or PR positive
Patients ECOG score must be 0-2
Drug resistant about Non-Steroid Aromatase Inhibitors

Exclusion Criteria:

Not suitable for endocrine therapy
Have receive the standard Steroid Aromatase Inhibitors treatment
Severe hepatic dysfunction

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yehui Shi, MD	Contact	022-23340123-1052		shiyehui@tom.com

Overall Officials

Name	Affiliation	Role
Yehui Shi, M.D.	Tianjin Medical University Cancer Institute and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University Cancer Institute and Hospital	Recruiting	Tianjin	Tianjin Municipality	300060	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D016097	Simian Acquired Immunodeficiency Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided