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New treatment option for Oligometastatic Breast Carcinoma
Official title 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 ID: NCT05534438
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Allentown, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.