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Breast Cancer Molecular Analysis Prior to Investigational Therapy

Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

Breast Cancer Molecular Analysis Prior to Investigational Therapy

Inclusion Criteria:

1. All patients with metastatic breast cancer who are considered for further systemic
therapy are eligible regardless of number of prior therapies.

2. Patient must have a metastatic lesion that could be safely biopsied with or without
image-guidance. The final arbiter to decide what lesion can be biopsied is the
physician who will perform the biopsy.

3. There is no age limit for this study. However, this study will not include children
because metastatic breast cancer does not occur in children.

4. Patients may participate in the biopsy study multiple times to repeat molecular
assessment of the cancer after progression.

5. Patients who undergo routine clinical biopsy of metastatic breast cancer are also
eligible to participate in this study. When the routine biopsies are obtained for
diagnostic or other purposes, additional biopsies will be taken during the same
biopsy session for molecular analysis.

Exclusion Criteria:

1. Known medical contraindication for needle biopsy procedure such as bleeding disorder,
low platelet count, inability to provide informed consent

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

molecular analysis of metastatic breast cancer using DNA sequencing

Outcome Description:

The primary goal is to survey the known DNA abnormalities with potential therapeutic relevance in cancer and steer patients to therapies that target the detected abnormalities.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lajos Pusztai, M.D., D.Phil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Data and Safety Monitoring Board

Study ID:

HIC# 1210010985



Start Date:

May 2013

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic
  • Breast Cancer
  • Metastatic Breast Cancer
  • Breast
  • Biopsy
  • Molecular
  • Genetic
  • Breast Neoplasms



Smilow Hospital Breast CenterNew Haven, Connecticut  06520-8032