Breast Cancer Molecular Analysis Protocol

Metastatic Breast Cancer Clinical Trial

— MAP-IT  

Official title:

Breast Cancer Molecular Analysis Prior to Investigational Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855503
• Other study ID #: HIC# 1210010985
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: November 16, 2016
• Start date: May 2013

Study information

• Verified date: November 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Procedure:
• Core Biopsy

Locations

Country	Name	City	State
United States	Smilow Hospital Breast Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Foundation Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	molecular analysis of metastatic breast cancer using DNA sequencing	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.	2 years	No
Secondary	To establish a metastatic breast cancer tissues resource for future research	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.	2 years	No