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Biomarkers in Tissue Samples From Older Women With Breast Cancer

This study has been terminated.
(Study closed prematurely.)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: April 30, 2011
Last updated: July 1, 2016
Last verified: July 2016
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.

Condition Intervention
Breast Cancer Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Breast cancer-free interval for patients with PIK3CA-mutated tumors [ Time Frame: baseline ]
  • Tumor size [ Time Frame: baseline ]
  • Estrogen receptor status [ Time Frame: baseline ]
  • Lymph node status [ Time Frame: baseline ]
  • Treatment group associated with PIK3CA expression [ Time Frame: baseline ]

Secondary Outcome Measures:
  • Overall survival associated with PIK3CA [ Time Frame: baseline ]
  • Breast cancer specific survival associated with PIK3CA expression [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA

Enrollment: 505
Study Start Date: April 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: laboratory biomarker analysis
    Correlative sciences
Detailed Description:


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.


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


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01346579

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Mary Ellen Moynahan, MD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT01346579     History of Changes
Other Study ID Numbers: CALGB-151101
CDR0000699810 ( Registry Identifier: NCI Physician Data Query )
Study First Received: April 30, 2011
Last Updated: July 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA breast cancer
stage IB breast cancer
estrogen receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 20, 2017