← Back to Search

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

Metastatic breast cancer, biopsy proven

ECOG performance status 0-1

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

Select...

My breast cancer has spread, confirmed by a biopsy.

Select...

I am fully active or can carry out light work.

Select...

My cancer is mainly driven by estrogen receptors.

Select...

My cancer is HER2 positive, no matter the ER status.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months from start of sbrt delivery

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%

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,886 Total Patients Enrolled

202 Trials studying Breast Cancer

81,097 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

Recent research and studies

clinicaltrials.govStudy

A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

2022. "A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05534438.

All > Breast Cancer Hawaii