Targeted Radiation Therapy for Metastatic Breast Cancer
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Recruiting
Phase 2Interventional Study
Oligometastatic Breast CarcinomaBreast CancerMetastatic Breast CancerMetastatic Breast CarcinomaER+ Breast CancerHER2+ Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for people with metastatic breast cancer to see if adding targeted radiation therapy to their regular drug treatment can help manage their cancer. Participants will continue their usual drug treatment while receiving the radiation therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I can provide informed consent
I have been diagnosed with metastatic breast cancer
I have ER+/HER2- or HER2+ breast cancer
I have had at least 6 months of effective systemic therapy
I have an isolated area where the cancer has worsened
I have an ECOG performance status of 0-1
You may not be able to join if
I am pregnant
I have a serious medical condition that prevents radiation
I have any problems in my brain related to cancer
I have had previous radiation treatment at the area planned for radiation
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants'…
The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Age 18 or older
* Willing and able to provide informed consent
* Metastatic breast cancer, biopsy proven
* ER+/HER2-, defined as \>5% ER+ staining
* HER2+ (regardless of ER status), including HER2-low and high expressors
* History of at least 6 months, sustained response …
Inclusion Criteria:
* Age 18 or older
* Willing and able to provide informed consent
* Metastatic breast cancer, biopsy proven
* ER+/HER2-, defined as \>5% ER+ staining
* HER2+ (regardless of ER status), including HER2-low and high expressors
* History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)
* Isolated site of disease progression on FDG PET scan
* Consented to 12-245
* ECOG performance status 0-1
Exclusion Criteria:
* Pregnancy
* Serious medical comorbidity precluding radiation, including connective tissue disorders
* Intracranial disease (including previous intracranial involvement)
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
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