Biomarkers in Tissue Samples From Older Women With Breast... | NCT01346579

Studies
Biomarkers in Tissue Samples From Older Women With Breast Cancer

NCT01346579

Sponsor

Alliance for Clinical Trials in Oncology

Status

Terminated

Last Update Posted

Jul 4, 2016Estimated

Enrollment

505Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

laboratory biomarker analysis

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

ID	Type	Description	Link
CDR0000699810	Registry Identifier	NCI Physician Data Query

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study closed prematurely.

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Apr 30, 2011

First Submission Date that Met QC Criteria

Apr 30, 2011

First Posted Date

May 3, 2011Estimated

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

Jul 1, 2016

Last Update Posted Date

Jul 4, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

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

This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed Description

PRIMARY OBJECTIVES:

To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer.

OUTLINE:

Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.

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

Retention

Enrollment

505Actual

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other	Correlative sciences

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breast cancer-free interval for patients with PIK3CA-mutated tumors		baseline
Tumor size		baseline
Estrogen receptor status		baseline
Lymph node status		baseline
Treatment group associated with PIK3CA expression		baseline

Secondary Outcomes

Measure	Description	Time Frame
Overall survival associated with PIK3CA		baseline
Breast cancer specific survival associated with PIK3CA expression		baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Participants with stage I breast cancer (T1N0M0) and estrogen-receptor status positive or unknown
Patients underwent lumpectomy with negative margins and were clinically node-negative

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients with breast cancer enrolled on Cancer and Leukemia Group B 9343

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Ellen Moynahan, MD	Memorial Sloan Kettering Cancer Center	Study Chair

Locations

Not provided

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