Biomarkers in Tissue Samples From Older Women With Breast Cancer

NCT ID: NCT01346579

Last Updated: 2016-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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laboratory biomarker analysis

Correlative sciences

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Ellen Moynahan, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Other Identifiers

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CDR0000699810

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-151101

Identifier Type: -

Identifier Source: org_study_id

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