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Peptide Profiles of Women Undergoing Breast Biopsy

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Peptide Profiles of Women Undergoing Breast Biopsy

Despite currently available screening techniques, only 63% of breast cancer cases are
diagnosed at a localized stage, for which the 5-year survival rate exceeds 95% (1). Advances
in breast imaging are occurring, but further efforts to detect breast cancer at an early
stage would be beneficial. Recently, new technologies which use mass spectrometric analysis
to characterize the overall pattern of peptide expression in the serum or plasma have been
developed. Preliminary studies have suggested that peptide profiles can be used to
differentiate cancer patients from those without cancer for a variety of malignancies
including breast cancer. If mass spectrometric analysis is able to detect differences in
peptide profiles between early stage breast cancers and normal controls, this technique
could be developed as a screening modality.

The objective of the present study which is entitled "Peptide Profiles of Women Undergoing
Breast Biopsy" is to determine whether the diagnosis of malignancy on breast biopsy is
associated with a specific serum or plasma peptide profile which can be distinguished from
the peptide profile associated with benign diagnoses on breast biopsy. To accomplish this,
blood samples will be collected from 500 women undergoing breast biopsy and 100 women with
metastatic disease. Samples will be obtained prior to the biopsies and analyzed by mass
spectrometry. Residual material will be shared with investigators of the National Cancer
Institute Clinical Proteomics Technology Assessment Consortium.

Inclusion Criteria:

- Female

- Age ≥ or = to 18

Cohort A: Biopsy Cohort:

- Referred by a healthcare provider for breast biopsy

- No prior history of invasive breast cancer OR of ductal carcinoma in situ

- No prior history of other malignancies within 5 years except cervical dysplasia,
squamous cell carcinoma of the skin or basal cell carcinoma of the skin Cohort B:
Metastatic Disease Cohort - Diagnosis of stage IV breast cancer

Exclusion Criteria:

- Male

- Age < 18

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mark Robson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast biopsy
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021