Breast CancerPhase 2NCT02482376
Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer
A Phase 2 study testing Stereotactic body radiotherapy ( SBRT) in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereotactic body radiotherapy ( SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2015to 10 Mar 2032
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
- Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
- Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm
- 60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.
- Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
Show all 10Show fewer
- Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
- White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent
- Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.
- Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.
Who cannot join
- Neoadjuvant chemotherapy
- Breast implant in the breast to be treated with SBRT
- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
- Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
- HER2 positive
- Positive serum pregnancy test
Show all 9Show fewer
- Insufficient breast imaging to judge clinical stage
- Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
- Subjects in whom treatment planning constraints cannot be met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response
This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100).
The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale
Read the detailed description
The study team hypothesizes that a single fraction of 21Gy can be delivered preoperatively to the intact breast tumor with acceptable cosmetic outcomes. Furthermore, the investigators anticipate that pre- and post-radiation breast tumor samples will provide an avenue for understanding breast cancer radiation response
Rationale for single-fraction preoperative technique
This trial is proposed to build on the favorable results of the investigators' phase I trial by extending the findings to a larger cohort of subjects. The preoperative approach has several advantages:
- a small intact breast tumor results in significantly less uninvolved breast tissue receiving high radiation doses which likely decreases toxicity;
- more accurate targeting of the high-risk areas of subclinical disease surrounding the tumor is possible,
- smaller treatment volumes are amenable to dose escalation which can further accelerate treatment and improve accessibility for subjects,
- this technical approach is widely utilized in other tumor sites and can be delivered at most radiation facilities
- the pre-operative approach provides a novel opportunity to study breast cancer radiation response.
- Conditions
- Breast Cancer
- Being tested
- Stereotactic body radiotherapy ( SBRT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy ( SBRT)Radiation
Also called SBRT
Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Single arm 21Gy stereotactic radiotherapy | Other | Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery. Receives: Radiation: Stereotactic body radiotherapy ( SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 6 months
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 1 year
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 2 years
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis.
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 3 years
Secondary outcomes (6)
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: baseline
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 6 months
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 12 months
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 2 year
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Measured: 3 year
Local Control in the Treated Breast Relative to Historic Controls
Local control consists of annual clinical examination combined with breast imaging
Measured: Through study completion estimated to be 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start21 Oct 2015
- Primary completion10 Mar 2025
- Study completion10 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Rachel Blitzblau, MD PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482376
- Sponsor's protocol ID
- Pro00063848
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2015
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response
- ClinicalTrials.gov ID
- NCT02482376
- Acronym / sponsor ID
- Pro00063848
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Gateway for Cancer Research
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2032 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Posted 17 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100).
The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale
Detailed description
The study team hypothesizes that a single fraction of 21Gy can be delivered preoperatively to the intact breast tumor with acceptable cosmetic outcomes. Furthermore, the investigators anticipate that pre- and post-radiation breast tumor samples will provide an avenue for understanding breast cancer radiation response
Rationale for single-fraction preoperative technique
This trial is proposed to build on the favorable results of the investigators' phase I trial by extending the findings to a larger cohort of subjects. The preoperative approach has several advantages:
- a small intact breast tumor results in significantly less uninvolved breast tissue receiving high radiation doses which likely decreases toxicity;
- more accurate targeting of the high-risk areas of subclinical disease surrounding the tumor is possible,
- smaller treatment volumes are amenable to dose escalation which can further accelerate treatment and improve accessibility for subjects,
- this technical approach is widely utilized in other tumor sites and can be delivered at most radiation facilities
- the pre-operative approach provides a novel opportunity to study breast cancer radiation response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm 21Gy stereotactic radiotherapy | Other | Radiation: Stereotactic body radiotherapy ( SBRT)Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
- Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm
- 60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.
- Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
Key exclusion criteria (9 listed)
- Neoadjuvant chemotherapy
- Breast implant in the breast to be treated with SBRT
- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
- Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
- HER2 positive
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 |
|---|---|---|
| Stereotactic body radiotherapy ( SBRT)Also: SBRTSingle fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer | Radiation | Single arm 21Gy stereotactic radiotherapy |
Primary outcome
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
Time frame: 6 months
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
Time frame: 1 year
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
Time frame: 2 years
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis.
Time frame: 3 years
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
6 secondary outcomes
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Time frame: baseline
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Time frame: 6 months
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Time frame: 12 months
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Time frame: 2 year
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
Time frame: 3 year
Local Control in the Treated Breast Relative to Historic Controls
Time frame: Through study completion estimated to be 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
Rachel Blitzblau, MD PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiotherapy ( SBRT) in people with Breast Cancer, run by Duke University 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis (time frame: 6 months). The study lists 4 primary outcomes in all. 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 Mar 2026.