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Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells

NCT03070002 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-11-20

Study results available
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Summary

The purpose of this study is to look at the amount of cancer cells in the blood of participants who are being treated with denosumab. The other purpose is to look at how long it takes for cancer to get worse when participants are being treated with denosumab. Circulating tumor cells (CTCs) in the blood of patients with metastatic breast cancer (MBC) have been associated with shorter survival than when CTCs are absent, especially in patients whose cancer has spread to their bones. In this study, we want it see if denosumab (the study drug) will decrease the number of CTCs measured in patients with MBC and cancer that has spread to their bones. We also plan to get blood from participants to study other research markers of interest.

Conditions

  • Breast Carcinoma Metastatic in the Bone
  • Circulating Tumor Cell Count
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Progesterone Receptor Positive
  • Stage IV Breast Cancer

Interventions

BIOLOGICAL

Denosumab

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Sarika Jain, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2018-03-06
Completion
2018-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070002 on ClinicalTrials.gov