NCT07122713 · Alexander Stessin
Definitive Radiation Therapy for Inoperable Breast Cancer
(DEFINE)
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor
Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions
RADIATION
Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
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
Primary outcome measures
Treatment Safety
Time frame: 12 months
Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
- T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
- Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
- Life expectancy \> 6 months
- Negative pregnancy test at the time of start of treatment in any female of reproductive age
Exclusion criteria
- Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
- Prior radiation to ipsilateral breast or regional nodes
- Inability to receive study treatment planning and treatment secondary to body habitus
Where
- Stony Brook, New York
Collaborators
Northwell Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations