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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
  Purpose

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.


Condition Intervention
Breast Cancer
 Genetic: DNA analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: medical chart review

Study Type: Observational
Official Title: PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Breast cancer-free interval of patients with PIK3CA-mutated tumors as compared to wild-type tumors [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 505
Study Start Date: April 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346579

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mary Ellen Moynahan, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01346579     History of Changes
Other Study ID Numbers: CDR0000699810, CALGB-151101
Study First Received: April 30, 2011
Last Updated: May 3, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
estrogen receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013