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Targeted Radiation + Drug Therapy for Breast Cancer

Phase 2
Recruiting
Led By Amy Xu, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)
Metastatic breast cancer, biopsy proven
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from start of sbrt delivery
Awards & highlights

Study Summary

This trial is testing whether adding SBRT to the usual cancer drug therapy can help people with oligometastatic breast cancer by preventing the cancer from worsening in other metastatic sites or spreading.

Who is the study for?
This trial is for adults with metastatic breast cancer who've had a good response to drug therapy for at least 6 months. It's open to those with certain hormone receptor statuses, able to consent, and have only one site of disease progression visible on a scan. Pregnant individuals, those with previous radiation at the target site or brain involvement, and serious medical conditions that conflict with radiation are excluded.Check my eligibility
What is being tested?
The study tests adding Stereotactic Body Radiation Therapy (SBRT) targeting just one metastatic site alongside ongoing usual drug therapy in people with oligometastatic breast cancer. The goal is to see if this precise radiation can prevent the cancer from getting worse elsewhere.See study design
What are the potential side effects?
Potential side effects of SBRT may include skin reactions, fatigue, pain at the treatment site, and rarely more severe issues like damage to nearby organs or tissues depending on where the treatment is aimed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My treatment for cancer has been working for at least 6 months without getting worse.
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My breast cancer has spread, confirmed by a biopsy.
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I am fully active or can carry out light work.
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My cancer is mainly driven by estrogen receptors.
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My cancer is HER2 positive, no matter the ER status.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months from start of sbrt delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months from start of sbrt delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival

Side effects data

From 2018 Phase 4 trial • 19 Patients • NCT01344356
100%
Dizziness
100%
Cranial Nerve Neuropathy
100%
Fatigue
100%
Alopecia
100%
Mucositis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benign Tumors
Malignant Tumors

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with oligometastatic breast cancerExperimental Treatment1 Intervention
Participants with oligometastatic breast cancer with isolated progression after sustained (>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy
2014
Completed Phase 4
~370

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,310 Total Patients Enrolled
202 Trials studying Breast Cancer
81,210 Patients Enrolled for Breast Cancer
Amy Xu, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
174 Total Patients Enrolled

Media Library

Stereotactic body radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT05534438 — Phase 2
Breast Cancer Research Study Groups: Participants with oligometastatic breast cancer
Breast Cancer Clinical Trial 2023: Stereotactic body radiotherapy Highlights & Side Effects. Trial Name: NCT05534438 — Phase 2
Stereotactic body radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534438 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any harmful side effects to Stereotactic body radiotherapy?

"Although there is some data supporting its safety, the lack of evidence for efficacy gives stereotactic body radiotherapy a score of 2."

Answered by AI

How many individuals are experiencing this treatment?

"That is correct. The information available on clinicaltrials.gov reveals that this trial posted on September 6th, 2020 is still recruiting patients. 40 participants are needed and they will be chosen from 7 different locations."

Answered by AI

Are people still being enrolled in this clinical trial?

"The trial, which was initially posted on September 6th of this year, is currently recruiting according to the website clinicaltrials.gov"

Answered by AI

In how many different locations is this research project being conducted?

"There are 7 available for this trial such as Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) in Basking Ridge, and Memorial Sloan Kettering Westchester (Limited Protocol Activities) in Harrison. Other locations include 7 other locations."

Answered by AI
~18 spots leftby Sep 2025