Biomarkers in Tissue Samples From Older Women With Breast Cancer

This study has been terminated.
(Study closed prematurely.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01346579
First received: April 30, 2011
Last updated: June 12, 2015
Last verified: June 2015

April 30, 2011
June 12, 2015
April 2011
January 2014   (final data collection date for primary outcome measure)
  • Breast cancer-free interval for patients with PIK3CA-mutated tumors [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Tumor size [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Estrogen receptor status [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Lymph node status [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Treatment group associated with PIK3CA expression [ Time Frame: baseline ] [ Designated as safety issue: No ]
Breast cancer-free interval of patients with PIK3CA-mutated tumors as compared to wild-type tumors [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01346579 on ClinicalTrials.gov Archive Site
  • Overall survival associated with PIK3CA [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Breast cancer specific survival associated with PIK3CA expression [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Overall survival of patients with PIK3CA-mutated tumors [ Designated as safety issue: No ]
  • Breast cancer-specific survival of patients with PIK3CA-mutated tumors [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Biomarkers in Tissue Samples From Older Women With Breast Cancer
PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue

Non-Probability Sample

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

Breast Cancer
Other: laboratory biomarker analysis
Correlative sciences
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
505
January 2014
January 2014   (final data collection date for primary outcome measure)
  • 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
Female
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01346579
CALGB-151101, CDR0000699810
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Mary Ellen Moynahan, MD Memorial Sloan Kettering Cancer Center
Alliance for Clinical Trials in Oncology
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP