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| Name | Class |
|---|---|
| Gateway for Cancer Research | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm 21Gy stereotactic radiotherapy | Other | Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy ( SBRT) | Radiation | Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
a. 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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Blitzblau, MD PhD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
42 participants were withdrawn prior to starting study procedures due to insurance denial or ineligibility.
Women ages 60 or older with clinically node-negative, 2cm or less, biopsy proven ductal carcinoma in situ or invasive carcinoma seen in the Duke Radiation Oncology department were considered for this trial. Women age 50-59 with a cT1N0 tumor and a low Oncotype score were also eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm 21Gy Stereotactic Radiotherapy | Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery. Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
42 participants were withdrawn prior to starting study procedures due to insurance denial or ineligibility.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm 21Gy Stereotactic Radiotherapy | Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery. Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months |
|
Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm 21Gy Stereotactic Radiotherapy | Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery. Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office | Duke University Health System (DUHS) | 919-668-3726 | RadOnc-Clinical_Trials@dm.duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2025 | Dec 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| 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. | 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. | 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. | 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. | 3 year |
| Local Control in the Treated Breast Relative to Historic Controls | Local control consists of annual clinical examination combined with breast imaging | Through study completion estimated to be 10 years |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Data not collected on one participant. | Count of Participants | Participants |
|
| 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. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Primary | 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. | Only participants whose physician completed the cosmesis evaluation are included. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Primary | 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. | Only participants whose physician completed the cosmesis evaluation are included. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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. | Only participants who completed the cosmesis evaluation are included. | Posted | Count of Participants | Participants | 2 year |
|
|
|
| Secondary | 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. | Only participants who completed the cosmesis evaluation are included. | Posted | Count of Participants | Participants | 3 year |
|
|
|
| Secondary | Local Control in the Treated Breast Relative to Historic Controls | Local control consists of annual clinical examination combined with breast imaging | Not Posted | Jan 2032 | Through study completion estimated to be 10 years | Participants |
| 2 |
| 68 |
| 5 |
| 68 |
| 48 |
| 68 |
| wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Fibrous deep connective tissue | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| volume loss | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Breast infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications, other | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Breast atrophy | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Reproductive system and breast disorders, other | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | includes post-operative swelling/edema/redness, tissue defects at the surgical site, volume loss |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders, other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | includes erythema, rash, scaly skin, skin reaction to tape, rash, blister/sunburn |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |