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Biomarkers in Tissue Samples From Older Women With Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT01346579
First received: April 30, 2011
Last updated: June 17, 2013
Last verified: April 2011

April 30, 2011
June 17, 2013
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.
 
Withdrawn
0
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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
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01346579
CDR0000699810, CALGB-151101
Not Provided
Alliance for Clinical Trials in Oncology ( 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
Alliance for Clinical Trials in Oncology
April 2011

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