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Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial

StatusRecruiting
PhasePhase 2
Started2024-10-11
View on ClinicalTrials.gov ↗

Amendment history

2026-07-06
Study Status, Eligibility v4
Eligibility criteria+416 characters
Inclusion Criteria: 1. Invasive epithelial (ductal, medullary, lobular, papillary, [...] ocrine or chemotherapy for current breast cancer diagnosis. For cohort 1, itIt is highly recommended thosethat these tumors are at least 1 cm for cohort 1 and less than 1 cm for cohort 2, however this is not required. 2. Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age >/= 18 years old and female If 4.the Greatesttumor Tumoris unifocal, greatest tumor dimension is 3cm or less based on USimaging. MRIMultifocal measurementsdisease canmay be included only if perform [...] [...]
2025-11-03
Study Status v3
Re-verified, no change to tracked fields
2024-10-28
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-01→confirmed 2024-10-11
Study sitesdetails revised at 1 of 1 site
2024-07-31
Study Status v1
Start date2024-07-01→2024-10-01
2024-05-30
Original filing
1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
Trial Details
NCT Number NCT06444269
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Breast Cancer
Enrollment 53 participants
Start Date 2024-10-11
Primary Completion 2027-07-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-08