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Biomarker Study of Breast Tumors

18 Years
Open (Enrolling)
Breast Tumors

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Trial Information

Biomarker Study of Breast Tumors

Abstract of Research Proposal:

Breast cancer is a heterogeneous disease, with various subtypes demonstrating differing
biological behavior, prognosis, and response to therapeutic agents. Improving the
understanding of the biology of breast cancer can result in better prognostication and
therapy in individual patients, and has important clinical implications. While valuable
scientific knowledge is generated from studies of breast cancer cell lines or animal models,
such information generated in vitro may not fully reflect the in vivo model. Direct analysis
of patient samples is important to validate in vitro findings, and represents a step closer
to clinical application. Studying patient tumor samples for genetic and protein markers and
correlating these analyses with clinical characteristics and outcomes could provide valuable
insights into tumor biology in vivo, and leads to better understanding of tumor biology and
resistance mechanisms. This is a single-centre study of biomarker analysis in breast tumors.
A total of 400 patients with breast lesions for whom a diagnostic core biopsy is planned
will be enrolled over 2 years. During the diagnostic tumor core biopsy, 3-4 additional tumor
samples will be obtained through the same needle track for the purpose of this study. The
tumor cores will be stored in liquid nitrogen for subsequent histopathological analysis;
DNA, RNA and protein will be extracted from tumor cores for genetic, gene expression and
proteomics studies. The patient's clinical progress will be tracked through the clinical
case files. For patients in whom the clinical diagnostic biopsy yields a benign result, the
samples obtained from them will serve as control specimens. For patients in whom the
clinical diagnostic core biopsy confirms the diagnosis of breast cancer, the samples will be
considered cases, and the following information will be tracked: histopathological
characteristics of the tumor including ER/PR/c-erbB2 status and other known prognostic and
predictive immunohistochemical markers (e.g., Ki67, p53, etc), anti-cancer treatment,
progression-free and overall survival.

Inclusion Criteria:

- Age >= 18 years.

- Suspicious breast lesion for which diagnostic core biopsy is planned.

- Patients must not have received prior or scheduled to receive chemotherapy, hormonal
therapy, radiotherapy, targeted therapy, or immunotherapy for the treatment of breast

- Signed informed consent from patient or legal representative.

Exclusion Criteria:

- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Principal Investigator

Soo Chin Lee, MBBS, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Breast Tumors
  • Breast Neoplasms