Breast Cancer Molecular Analysis Protocol

NCT01855503 — Completed, 121 participants, Yale University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Breast Cancer Molecular Analysis Prior to Investigational Therapy

Registry	NCT01855503, acronym MAP-IT
Status	Completed
Study type	Observational
Enrollment	121 (Actual)
Sponsor	Yale University (Other); collaborators: Foundation Medicine
Conditions	Metastatic Breast Cancer
Interventions	Core Biopsy (Procedure)
Dates	start 2013-05-01, primary completion 2016-08-01, first posted 2013-05-16, last updated 2016-11-17
Locations	1 site in United States

-Summary

This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Metastatic Breast Cancer		Procedure: Core Biopsy

Core Biopsy (Procedure)

+Outcome measures

Primary outcomes

molecular analysis of metastatic breast cancer using DNA sequencing [2 years]: 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.

Secondary outcomes

To establish a metastatic breast cancer tissues resource for future research [2 years]: The secondary objective is to establish a metastatic breast cancer tissues resource for future research to learn about biological events that drive metastatic cancer and to identify novel therapeutic targets and predictors of response to therapy.

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Smilow Hospital Breast Center	New Haven, Connecticut	United States

+Investigators

Lajos Pusztai, M.D., D.Phil, Principal investigator, Yale University

My Notes

Public

To Read Reading Read