This trial is active, not recruiting.

Conditions breast cancer, breast cancer non-invasive breast cancer, breast cancer early stage breast cancer (stage 1-3)
Treatment breast tissue, lymph node tissue or blood
Sponsor Stanford University
Collaborator National Institutes of Health (NIH)
Start date May 1996
End date May 2050
Trial size 99999 participants
Trial identifier NCT00569049, 1028313-100-JAACC, 1045090-101-KBAHQ, 10EB-10086; 11IB-0175, 75026, 8EB-1106, BRSNSTU0001, CA085129; 1R01CA109325-01, SU-11052007-799


This is a research-based study that is looking at the biologic features of breast tissue, lymph node tissue, or blood in order to study breast cancer development growth, and spread. Through tissue and/or blood samples we hope to gain further knowledge and understanding of how to improve diagnosis and treatment of breast cancer by identifying the molecular markers that predict clinical outcome and response to therapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria:People eligible for this study include anyone older than 18 years who is undergoing one of the following procedures: core needle or surgical breast biopsy, lumpectomy, mastectomy, axillary lymph node surgery, breast reduction surgery, or ductal lavage or ductoscopy. Patients who have had breast cancer in the past who are currently free of disease or who have a breast cancer recurrence are also eligible. All patients who participate must be able to understand and sign the informed consent. Although most patients will be female, any males undergoing the above procedures are also eligible for this study. Exclusion Criteria:Any patient who is less than 18 years old, who is unable to understand the informed consent, or not undergoing the above procedures will be excluded from this research.

Additional Information

Official title Molecular Analysis of Breast Cancer
Principal investigator Stefanie S. Jeffrey M.D.
Description The tissue obtained in this protocol will be used for genome-wide examination of DNA, RNA expression profiling, proteomic analyses, isolation and analyses of normal and cancer stem cells, isolation and analyses of circulating tumor cells, possible analyses of immune cells, and possible analyses of serum factors. The tissue may also be used to develop patient-specific cell culture models or mouse xenograft models of breast cancer for biologic study of tumor progression and metastases and for therapeutic testing. In general, the tissue will be used in studies that will molecularly classify tumors, identify prognostic markers, identify potential therapeutic markers, identify potential treatment targets, and help us better understand the biology and specific role played by different tumor cells in the metastatic process. The ultimate goal is to use molecular analyses to improve the diagnosis and treatment of breast cancer.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Stanford University.