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Biomarkers in Tissue Samples From Older Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01346579
First received: April 30, 2011
Last updated: May 3, 2011
Last verified: April 2011
History of Changes

April 30, 2011
May 3, 2011
April 2011
May 2011   (final data collection date for primary outcome measure)
Breast cancer-free interval of patients with PIK3CA-mutated tumors as compared to wild-type tumors [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01346579 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Biomarkers in Tissue Samples From Older Women With Breast Cancer
PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in tissue samples from older women with breast cancer.

OBJECTIVES:

  • To validate PIK3CA mutation status as a biomarker in women 70 years or older diagnosed with breast cancer.

OUTLINE: Genomic DNA extracted from archived tumor tissue samples are analyzed for mutation by Sequenom multiplex massARRAY (multiplex PCR and mass spectroscopy). Results are then analyzed by massARRAY TyperAnalyzer v4.0 software. Patients clinical data are also analyzed, including treatment received.
Observational
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Breast Cancer
  • Genetic: DNA analysis
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Other: mass spectrometry
  • Other: medical chart review
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
505
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May 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patients must have been registered to CALGB 9343

    • Stage I disease
    • Tumors ≤ 2 cm
    • Estrogen-receptor positive (ER+)
    • Lymph node negative
  • Paraffin block or slides of the primary tumor must be available and have been submitted to the CALGB Pathology Coordinating Office

PATIENT CHARACTERISTICS:

  • Consented to future research participation

PRIOR CONCURRENT THERAPY:

  • Not specified
Female
70 Years and older
No
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NCT01346579
CDR0000699810, CALGB-151101
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Principal Investigator: Mary Ellen Moynahan, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
April 2011

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