Biomarkers in Tissue Samples From Older Women With Breast Cancer

This study has been withdrawn prior to enrollment.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

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:

Further study details as provided by Alliance for Clinical Trials in Oncology:

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 ]

Enrollment: 0
Study Start Date: April 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


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


  • 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


  • Consented to future research participation


  • Not specified
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Please refer to this study by its identifier: NCT01346579

Sponsors and Collaborators
Cancer and Leukemia Group B
Principal Investigator: Mary Ellen Moynahan, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B ) Identifier: NCT01346579     History of Changes
Other Study ID Numbers: CDR0000699810, CALGB-151101
Study First Received: April 30, 2011
Last Updated: June 17, 2013
Health Authority: Unspecified

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 by Site
Skin Diseases processed this record on May 26, 2015