Stony Brook University Cancer Center
Stony Brook, New York, 11794, United States
Location status: Recruiting
Location contact
Alexander Stessin, MD PhD
PRINCIPAL_INVESTIGATOR
Cancer Clinical Trials Office
CONTACT
CONTACT
NCT Number: NCT07122713
The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Stony Brook, New York, 11794, United States
Location status: Recruiting
Alexander Stessin, MD PhD
PRINCIPAL_INVESTIGATOR
Cancer Clinical Trials Office
CONTACT
CONTACT
Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions
Radiation with 26Gy to the whole breast and regional nodes with a 40Gy simultaneous integrated boost to gross disease in breast and ipsilateral axillary nodal areas, in five fractions
Time frame: 12 months
Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0
Time frame: 12 months
Percent of participants with any physician-assessed treatment-related Grade 1-5 events using CTCAE 5.0. Grade 1 events are limited to fatigue, skin, breast, ribs, heart and lungs.
Time frame: 5 years
Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.
Time frame: 2 years
Patient reported quality of life measured using the quality of life questionnaire C30 (QLQ-C30), developed by the European Organisation for Research and Treatment of Cancer. This scale includes 5 functional and 3 symptom scales, each scored as a 0-100 scale, where higher scores indicate a better outcome on functional scales and global health status, and a worse outcome on symptoms.
Time frame: 2 years
Patient reported quality of life measured using the quality of life questionnaire BR42 (QLQ-BR42), developed by the European Organisation for Research and Treatment of Cancer. This scale assesses symptoms, body image and sexual functioning scales, each scored as a 0-100 scale, where higher scores indicate worse outcome on symptoms.
Time frame: 1 year
Measured on follow-up MRI or CT imaging using RECIST criteria
Time frame: 1 year
Measured on follow-up MRI or CT imaging using RECIST criteria
Time frame: 1 year
Caliper measurements (2-dimensional)
Contact information is provided by the study sponsor or research team.
Caterina Stony Brook Cancer Center Clinical Trials
CONTACT
Caterina Vacchi-Suzzi, PhD
CONTACT
Alexander Stessin
Other
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Acronym: DEFINE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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