A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic body radiotherapy.
- Who it may be relevant to
- Registry conditions: Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Overview
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.
Interventions
- Radiation Stereotactic body radiotherapy
SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)
Primary outcome measures
- Progression free survival [Time frame: 3 months from start of SBRT delivery]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale
- Lehigh Valley Health Network (Data Collection Only) — Allentown
Identifiers
NCT: NCT05534438 · 22-259