This phase II trial studies how well stereotactic accelerated partial breast irradiation (SPBI) given before breast surgery (pre-operative) works in treating early stage hormone receptor-positive breast cancer and to see if microbubble-ultrasound can be used for the imaging of sentinel lymph nodes (SLN) during biopsy. SPBI is a type of partial breast irradiation that treats the breast tumor and/or area around the tumor instead of the whole breast. This allows for treatment intensification while protecting normal breast tissue from unnecessary high-dose irradiation. Giving SPBI pre-operatively may shrink the tumor which may make it easier for the tumor to be removed during breast surgery. Microbubble-ultrasound uses a microbubble contrast injected into the areola. This may enhance the activity of the SLN during the ultrasound procedure and help to guide the SLN biopsy. Giving pre-operative SPBI may make it easier for the tumor to be removed during breast surgery and microbubble ultrasound may be better for the imaging of SLN in patients with early stage hormone receptor-positive breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06444269.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: Asal Shoushtari Rahimi
Phone: 214-645-8525
PRIMARY OBJECTIVES:
I. To determine efficacy of single fraction response adapted ablative pre-operative radiation in early stage estrogen receptor positive (ER+) breast cancer patients and determine pathologic complete response rate at 10-15 months after radiation.
II. To evaluate the potential of microbubble contrast enhanced ultrasound (CEUS) as a non-operative alternative to sentinel lymph node mapping and biopsy in early stage ER+ breast cancer patients undergoing pre-operative single fraction risk adapted ablative radiation.
IIa. Assess concordance of preoperative and pre-radiation microbubble CEUS with SLN mapping and biopsy at time of partial mastectomy.
III. To evaluate the potential of optoacoustic ultrasound imaging to non-invasively establish treatment response in patients undergoing preoperative single fraction risk adapted ablative radiation.
SECONDARY OBJECTIVES:
I. Acute toxicity (90 days).
II. Surgical morbidity rates.
EXPLORATORY OBJECTIVES:
I. To study biological determinants of response to pre-operative radiation therapy in early stage ER-positive breast cancer patients.
II. Patient and physician cosmesis at 3 years post radiation.
III. Late toxicity (24 months).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients with tumors ≥ 1cm receive sulfur hexafluoride lipid microspheres (Lumason) intradermally at the areola and undergo non-operative microbubble contrast enhanced sentinel lymph node biopsy (SNLB) prior to radiation. Patients then undergo one SPBI treatment fraction on day 1. Starting between days 14-24, patients receive standard of care (SOC) endocrine therapy. Patients with no residual disease at month 9 undergo SOC breast surgery with SNLB between months 10-12. Patients with residual disease at month 9 receive personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) boost to residual disease and undergo SOC surgery with SNLB between months 12-15. Additionally, patients undergo mammography or ultrasound imaging, optoacoustic (OA) ultrasound imaging, magnetic resonance imaging (MRI), blood sample collection, and tumor biopsy throughout the trial.
COHORT II: Patients with tumors < 1cm undergo SPBI over 1-2 treatment starting on day 1. Starting between days 14-24, patients receive SOC endocrine therapy. Patients with no residual disease at month 9 undergo SOC surgery with SNLB between months 10-12. Patients with residual disease at month 9 receive PULSAR boost to residual disease and undergo SOC breast surgery with SNLB between months 12-15. Additionally, patients undergo mammography or ultrasound imaging and tumor biopsy throughout the trial. Patients may optionally undergo OA ultrasound imaging, MRI, and blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 2-3 months post-radiation and 6, 12, 24, and 36 months after study treatment.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorAsal Shoushtari Rahimi
