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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00128074 | Other Identifier | JHM IRB |
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PI closed. Unable to enroll enough patients to collect and analyze data.
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| Name | Class |
|---|---|
| Robert L. Sloan Fund for Cancer Research | OTHER |
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This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT to the breast then surgery | Experimental | Stereotactic Body Radiation Therapy (SBRT) of 21Gy followed by standard of care surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy SBRT | Radiation | Stereotactic Body Radiation Therapy to the breast to 21 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response Measured by Residual Cancer Burden (RCB) | Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors. | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Toxicity | The number of participants with severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery, up to 4 months. | RT delivery up to 90 days after completion of surgery, up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
females only
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| Name | Affiliation | Role |
|---|---|---|
| Jean Wright, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| Johns Hopkins Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | SBRT to the Breast Then Surgery | Stereotactic Body Radiation Therapy of 21Gy to the breast followed by standard of care surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiation Therapy to the Breast Then Surgery | Stereotactic Body Radiation Therapy (SBRT) of 21 Gy to the breast, followed by standard of care surgery. |
| 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 | Treatment Response Measured by Residual Cancer Burden (RCB) | Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors. | Posted | Count of Participants | Participants | 4-6 weeks |
|
|
Up to 4 months
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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 | SBRT to the Breast Then Surgery | Stereotactic Body Radiation of 21 gy followed by standard of care surgery Stereotactic Body Radiation SBRT: Stereotactic Body Radiation to the breast to 21 Gy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
Study was terminated early, only 4 participants were enrolled. Enrollment was too challenging to continue the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Baker Kaplin, MPH | Johns Hopkins University, Department of Radiation Oncology | 410-614-3950 | dkaplin1@jhmi.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 10, 2023 | Jul 19, 2024 | 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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SBRT to the breast follow by standard of care surgery
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| Cosmetic Outcome (Patients) |
Number of patients who report poor cosmetic outcomes from patient perspective at 90 days after pre-operative SBRT to intact breast tumors using the Radiation therapy oncology group (RTOG) cosmesis scale and digital images. RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor) |
| 90 days |
| Local Recurrence | To measure local recurrence in participants | 1 year |
| Breast Cancer Treatment Outcomes Scale (BCTOS) | To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS). The BCTOS is a questionnaire that evaluates the aesthetic and functional outcomes of breast conserving surgery (BCS). Patients rate each item on the questionnaire using a four-point Likert scale, with 1 indicating no difference and 4 indicating a large difference between the treated and untreated breast. Score range 22-88. Higher scores indicate higher difference. | Pre and Post surgery (Up to 3 years) |
| Cosmetic Outcome (Provider) | Number of providers who report poor cosmetic outcomes from provider perspective at 90 days after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images. RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor) | 90 days |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Participants |
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| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Participants With Treatment-related Toxicity | The number of participants with severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery, up to 4 months. | Posted | Count of Participants | Participants | No | RT delivery up to 90 days after completion of surgery, up to 4 months |
|
|
|
| Secondary | Cosmetic Outcome (Patients) | Number of patients who report poor cosmetic outcomes from patient perspective at 90 days after pre-operative SBRT to intact breast tumors using the Radiation therapy oncology group (RTOG) cosmesis scale and digital images. RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor) | Posted | Count of Participants | Participants | 90 days |
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|
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| Secondary | Local Recurrence | To measure local recurrence in participants | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Breast Cancer Treatment Outcomes Scale (BCTOS) | To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS). The BCTOS is a questionnaire that evaluates the aesthetic and functional outcomes of breast conserving surgery (BCS). Patients rate each item on the questionnaire using a four-point Likert scale, with 1 indicating no difference and 4 indicating a large difference between the treated and untreated breast. Score range 22-88. Higher scores indicate higher difference. | Patients with data collected are reported. | Posted | Number | score on a scale | Pre and Post surgery (Up to 3 years) |
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|
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| Secondary | Cosmetic Outcome (Provider) | Number of providers who report poor cosmetic outcomes from provider perspective at 90 days after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images. RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor) | Posted | Count of Participants | Participants | 90 days |
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| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin Induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Participant 2, Pre-treatment |
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| Participant 2, Post surgery |
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| Participant 3, Pre-treatment |
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| Participant 4, Pre-treatment |
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