Biomarkers in Tissue Samples From Older Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346579
Recruitment Status : Terminated (Study closed prematurely.)
First Posted : May 3, 2011
Last Update Posted : July 4, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.

Condition or disease Intervention/treatment
Breast Cancer Other: laboratory biomarker analysis

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.

Study Type : Observational
Actual Enrollment : 505 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer
Study Start Date : April 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Other: laboratory biomarker analysis
    Correlative sciences

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

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

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   70 Years and older   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 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