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Radiation

SBRT and Imaging for Metastatic Breast Cancer

Phase 2

Recruiting

Led By Jose G Bazan

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Must not have

Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy

Patients that have only liver metastases will not be allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks post sbrt treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of a type of radiation therapy called stereotactic body radiation therapy (SBRT) in treating patients with estrogen receptor positive (ER +) breast cancer that has spread to

Who is the study for?

This trial is for individuals with estrogen receptor positive (ER+) breast cancer that has spread but shows limited progression. Participants should be currently on systemic treatment and able to undergo high-precision radiation therapy as well as PET/CT imaging using a tracer.

What is being tested?

The study tests Stereotactic Body Radiation Therapy (SBRT) to see if it can target tumor cells effectively, allowing patients to continue their current systemic treatments. It also evaluates the use of FES PET/CT imaging in detecting where the cancer has progressed.

What are the potential side effects?

Potential side effects from SBRT may include skin reactions, fatigue, pain at the site of treatment, and possible damage to nearby organs or tissues. The FES PET/CT imaging could cause allergic reactions or discomfort during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can perform daily activities with minimal assistance.

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My breast cancer is ER+ and can be any HER2 status.

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My growing cancer spots can be treated with targeted radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious illness that makes me unable to receive standard treatments.

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My cancer has not spread only to my liver.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline prior to sbrt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline prior to sbrt

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline prior to sbrt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients that remain on their original systemic therapy for at least ≥ 24 weeks post stereotactic body radiation therapy (SBRT) treatment

Secondary study objectives

Change in quality of life (QOL)

Number of lesions found on F-18 16 alpha fluoroestradiol positron emission tomography (FES-PET)

Progression free survival (PFS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT, FES PET/CT)Experimental Treatment7 Interventions

Patients currently taking SERMs/ SERDs immediately undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. Patients not currently taking SERMs/SERDs first receive F-FES IV and undergo PET/CT scans at baseline. After baseline FES PET/CT, patients with ≤ 4 sites of progressive disease then undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. All patients undergo FES PET/CT at 12 and 24 weeks. Patients with SD after 12 or 24 week FES PET/CT may continue standard systemic therapy. Patients with ≤ 4 sites of progressive disease after 12 or 24 week FES PET/CT may receive SBRT to additional sites in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. All patients also undergo CT, PET/CT, or bone scans, and blood samples collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Bone Scan

2015

Completed Phase 2

~50