Trial Outcomes & Findings for Study of Stereotactic Radiotherapy for Breast Cancer (NCT NCT03043794)
NCT ID: NCT03043794
Last Updated: 2024-09-19
Results Overview
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.
TERMINATED
PHASE2
4 participants
4-6 weeks
2024-09-19
Participant Flow
Participant milestones
| Measure |
SBRT to the Breast Then Surgery
Stereotactic Body Radiation Therapy of 21Gy to the breast followed by standard of care surgery
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
SBRT to the Breast Then Surgery
Stereotactic Body Radiation Therapy of 21Gy to the breast followed by standard of care surgery
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of Stereotactic Radiotherapy for Breast Cancer
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiation Therapy to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT) of 21 Gy to the breast, followed by standard of care surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
68.25 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeksNumber 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.
Outcome measures
| Measure |
SBRT to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy of 21Gy followed by standard of care surgery
|
|---|---|
|
Treatment Response Measured by Residual Cancer Burden (RCB)
RCB designation 0
|
1 Participants
|
|
Treatment Response Measured by Residual Cancer Burden (RCB)
RCB designation 1
|
3 Participants
|
SECONDARY outcome
Timeframe: RT delivery up to 90 days after completion of surgery, up to 4 monthsThe 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.
Outcome measures
| Measure |
SBRT to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy of 21Gy followed by standard of care surgery
|
|---|---|
|
Number of Participants With Treatment-related Toxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber 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)
Outcome measures
| Measure |
SBRT to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy of 21Gy followed by standard of care surgery
|
|---|---|
|
Cosmetic Outcome (Patients)
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearTo measure local recurrence in participants
Outcome measures
| Measure |
SBRT to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy of 21Gy followed by standard of care surgery
|
|---|---|
|
Local Recurrence
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre and Post surgery (Up to 3 years)Population: Patients with data collected are reported.
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.
Outcome measures
| Measure |
SBRT to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy of 21Gy followed by standard of care surgery
|
|---|---|
|
Breast Cancer Treatment Outcomes Scale (BCTOS)
Participant 1, Pre-treamtment
|
22 score on a scale
|
|
Breast Cancer Treatment Outcomes Scale (BCTOS)
Participant 1, Post surgery
|
31 score on a scale
|
|
Breast Cancer Treatment Outcomes Scale (BCTOS)
Participant 2, Pre-treatment
|
22 score on a scale
|
|
Breast Cancer Treatment Outcomes Scale (BCTOS)
Participant 2, Post surgery
|
23 score on a scale
|
|
Breast Cancer Treatment Outcomes Scale (BCTOS)
Participant 3, Pre-treatment
|
22 score on a scale
|
|
Breast Cancer Treatment Outcomes Scale (BCTOS)
Participant 4, Pre-treatment
|
22 score on a scale
|
SECONDARY outcome
Timeframe: 90 daysNumber 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)
Outcome measures
| Measure |
SBRT to the Breast Then Surgery
n=4 Participants
Stereotactic Body Radiation Therapy of 21Gy followed by standard of care surgery
|
|---|---|
|
Cosmetic Outcome (Provider)
|
0 Participants
|
Adverse Events
SBRT to the Breast Then Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SBRT to the Breast Then Surgery
n=4 participants at risk
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
|
|---|---|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Up to 4 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
25.0%
1/4 • Number of events 1 • Up to 4 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
25.0%
1/4 • Number of events 1 • Up to 4 months
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
25.0%
1/4 • Number of events 1 • Up to 4 months
|
Additional Information
Dana Baker Kaplin, MPH
Johns Hopkins University, Department of Radiation Oncology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place