Breast CancerDEFINENCT07122713
Definitive Radiation Therapy for Inoperable Breast Cancer
A study testing Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes in people with Breast Cancer and Breast Adenocarcinoma, run by Alexander Stessin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Adenocarcinoma
- What is being tested?
- Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to 30 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caterina Stony Brook Cancer Center Clinical Trials contact
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Cancer Center
Stony Brook, New York, 11794
Cancer Clinical Trials Office, (631)-728-7425, CancerClinicalTrials@stonybrookmedicine.edu
cancerclinicaltrials@stonybrookmedicine.edu
About this study
Official title: Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Breast Adenocarcinoma
- Being tested
- Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor, Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
- Keywords
- inoperable breast cancer, radiation therapy, breast radiation, novel treatment, new treatment breast, cyberknife, non-invasive, stereotactic radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumorRadiation
Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions
Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodesRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| A: Ipsilateral axillary node-negative breast cancer | Experimental | Patients with ipsilateral axillary lymph node-negative disease, regardless of metastatic status (Stages T1-4 N0 M0-1) Receives: Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor |
| B: Ipsilateral axillary node-positive breast cancer | Experimental | Patients with ipsilateral axillary node-positive disease, regardless of metastatic status (Stages T1-4 N1-2 M0-1) Receives: Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Safety
Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0
Measured: 12 months
Secondary outcomes (7)
Acute Toxicity
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.
Measured: 12 months
Late Toxicity
Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.
Measured: 5 years
Treatment Tolerability by EORTC QLQ-C30
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.
Measured: 2 years
Treatment Tolerability by EORTC QLQ-BR42
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.
Measured: 2 years
Tumor Response Rate in the Gross Disease Volume (40Gy)
Measured on follow-up MRI or CT imaging using RECIST criteria
Measured: 1 year
Progression Free Rate in the Microscopic Disease Volume (26Gy)
Measured on follow-up MRI or CT imaging using RECIST criteria
Measured: 1 year
Clinical Response in patients with Palpable Disease
Caliper measurements (2-dimensional)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start8 Dec 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Stessin
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health
- Responsible party
- Sponsor-investigator, Alexander Stessin, Stony Brook University
- Investigators
- Alexander Stessin, MD PhD, Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122713
- Sponsor's protocol ID
- SBU-BREAST-DEFINE
- Other IDs
- IRB2024-00364
- Acronym
- DEFINE
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
- ClinicalTrials.gov ID
- NCT07122713
- Acronym / sponsor ID
- DEFINE / SBU-BREAST-DEFINE
- Conditions
- Breast Cancer, Breast Adenocarcinoma
- Keywords
- inoperable breast cancer, radiation therapy, breast radiation, novel treatment, new treatment breast, cyberknife, non-invasive, stereotactic radiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexander StessinUniversity, hospital or other
- Collaborators
- Northwell Health
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2033 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Ipsilateral axillary node-negative breast cancer | Experimental | Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumorPatients with ipsilateral axillary lymph node-negative disease, regardless of metastatic status (Stages T1-4 N0 M0-1) |
| B: Ipsilateral axillary node-positive breast cancer | Experimental | Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodesPatients with ipsilateral axillary node-positive disease, regardless of metastatic status (Stages T1-4 N1-2 M0-1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumorRadiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions | Radiation | A: Ipsilateral axillary node-negative breast cancer |
| Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodesRadiation 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 | Radiation | B: Ipsilateral axillary node-positive breast cancer |
Primary outcome
Treatment Safety
Time frame: 12 months
Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0
7 secondary outcomes
Acute Toxicity
Time frame: 12 months
Late Toxicity
Time frame: 5 years
Treatment Tolerability by EORTC QLQ-C30
Time frame: 2 years
Treatment Tolerability by EORTC QLQ-BR42
Time frame: 2 years
Tumor Response Rate in the Gross Disease Volume (40Gy)
Time frame: 1 year
Progression Free Rate in the Microscopic Disease Volume (26Gy)
Time frame: 1 year
Clinical Response in patients with Palpable Disease
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caterina Stony Brook Cancer Center Clinical Trials contact
Alexander Stessin, MD PhD principal investigator
Stony Brook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes in people with Breast Cancer and Breast Adenocarcinoma, run by Alexander Stessin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caterina Stony Brook Cancer Center Clinical Trials (631-728-7425, cancerclinicaltrials@sronybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Safety (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.