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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 6, 2026 → Sep 6, 2027
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Record History

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  1. Primary and study completion pushed from Sep 6, 2026 to Sep 6, 2027
    • Eligibility criteria expanded, about 13 words
  2. Re-verified, no change to tracked fieldsv8
  3. Enrollment target: 40 to 46v7
  4. Primary and study completion dates: Sep 6, 2025 to Sep 6, 2026v6
  5. 2 versions Re-verified since Jul 8, 2024, no change to tracked fieldsv4-v5
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  1. Study sites revised (8)v3
  2. Study sites: 7 to 8v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05534438
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma, ER+ Breast Cancer, HER2+ Breast Cancer
Related terms Breast Neoplasms
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov