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
  Purpose

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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Tissue


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:

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders 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

Criteria
  • 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 ClinicalTrials.gov identifier: NCT01346579

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

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01346579     History of Changes
Other Study ID Numbers: CALGB-151101, CDR0000699810
Study First Received: April 30, 2011
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on June 28, 2015