NCT01346579

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

April 30, 2011

Last Update Submit

July 1, 2016

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerestrogen receptor-positive breast cancer

Outcome Measures

Primary Outcomes (5)

  • 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 (2)

  • Overall survival associated with PIK3CA

    baseline

  • Breast cancer specific survival associated with PIK3CA expression

    baseline

Interventions

laboratory biomarker analysisOTHER

Correlative sciences

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mary Ellen Moynahan, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2011

First Posted

May 3, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 4, 2016

Record last verified: 2016-07