Biomarkers in Tissue Samples From Older Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01346579
• Other study ID #: CALGB-151101
• Secondary ID: CDR0000699810
• Status: Terminated
• Phase: N/A
• First received: April 30, 2011
• Last updated: July 1, 2016
• Start date: April 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 505
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• laboratory biomarker analysis
Correlative sciences

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer-free interval for patients with PIK3CA-mutated tumors		baseline	No
Primary	Tumor size		baseline	No
Primary	Estrogen receptor status		baseline	No
Primary	Lymph node status		baseline	No
Primary	Treatment group associated with PIK3CA expression		baseline	No
Secondary	Overall survival associated with PIK3CA		baseline	No
Secondary	Breast cancer specific survival associated with PIK3CA expression		baseline	No