Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Procedure: Bone marrow aspirates and biopsy

• Registration Number: NCT01975597
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

This is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Primary Completion: 2014-11-19
• Study Completion: 2014-11-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients with metastatic breast cancer (any site) age 21 or older
• Patients willing and able to provide informed consent & perform study procedures
• Patients may enroll with recently (with 2 months) progressive tumor burden
• Performance status of 0,1 or 2

Exclusion Criteria

• Patients unable or unwilling to provide informed consent and or perform study procedures
• Patients with active, uncontrolled coagulopathy
• Patients on treatment dose anticoagulation or an International Normalised Ratio of 2 or greater if on warfarin
• Patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone marrow aspirates and biopsy	Bone marrow aspirates and biopsy	-

Primary Outcome Measures

Name	Time	Method
Number of patient that agree to undergo 2 biopsy's strictly for research purposes.	At 3 months

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States