Breast Cancer
Conditions
Keywords
early stage, low risk
Brief summary
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Detailed description
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.
Interventions
Stereotactic Body Radiation Therapy to the breast to 21 Gy
Sponsors
Robert L. Sloan Fund for Cancer Research
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SBRT to the breast follow by standard of care surgery
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Female sex * Age \> or = to 50 years of age * Invasive ductal carcinoma * Clinically and radiographically T1 tumor * Clinically node negative * Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior) * Planning breast conserving surgery including sentinel node biopsy * ≥10% expression of ER and/or PR * HER2- using the current College of American Pathologists guidelines * Post-menopausal * Willing and able to provide informed consent
Exclusion criteria
* Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma * Pure DCIS without invasive cancer * Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents * Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment * Positive pregnancy test * Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. * Unable to meet dosimetric constraints due to tumor location and/or patient anatomy * Planning mastectomy * Unable to tolerate prone positioning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response Measured by Residual Cancer Burden (RCB) | 4-6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Toxicity | RT delivery up to 90 days after completion of surgery, up to 4 months | 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. |
| Cosmetic Outcome (Patients) | 90 days | 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) |
| Local Recurrence | 1 year | To measure local recurrence in participants |
| Breast Cancer Treatment Outcomes Scale (BCTOS) | Pre and Post surgery (Up to 3 years) | 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. |
| Cosmetic Outcome (Provider) | 90 days | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Stereotactic Body Radiation Therapy to the Breast Then Surgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 68.25 Years |
| Race/Ethnicity, Customized White, not Hispanic | 4 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 4-6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SBRT to the Breast Then Surgery | Treatment Response Measured by Residual Cancer Burden (RCB) | RCB designation 0 | 1 Participants |
| SBRT to the Breast Then Surgery | Treatment Response Measured by Residual Cancer Burden (RCB) | RCB designation 1 | 3 Participants |
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.
Time frame: Pre and Post surgery (Up to 3 years)
Population: Patients with data collected are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SBRT to the Breast Then Surgery | Breast Cancer Treatment Outcomes Scale (BCTOS) | Participant 3, Pre-treatment | 22 score on a scale |
| SBRT to the Breast Then Surgery | Breast Cancer Treatment Outcomes Scale (BCTOS) | Participant 4, Pre-treatment | 22 score on a scale |
| SBRT to the Breast Then Surgery | Breast Cancer Treatment Outcomes Scale (BCTOS) | Participant 1, Pre-treamtment | 22 score on a scale |
| SBRT to the Breast Then Surgery | Breast Cancer Treatment Outcomes Scale (BCTOS) | Participant 1, Post surgery | 31 score on a scale |
| SBRT to the Breast Then Surgery | Breast Cancer Treatment Outcomes Scale (BCTOS) | Participant 2, Pre-treatment | 22 score on a scale |
| SBRT to the Breast Then Surgery | Breast Cancer Treatment Outcomes Scale (BCTOS) | Participant 2, Post surgery | 23 score on a scale |
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)
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT to the Breast Then Surgery | Cosmetic Outcome (Patients) | 0 Participants |
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)
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT to the Breast Then Surgery | Cosmetic Outcome (Provider) | 0 Participants |
Secondary
Local Recurrence
To measure local recurrence in participants
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT to the Breast Then Surgery | Local Recurrence | 0 Participants |
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.
Time frame: RT delivery up to 90 days after completion of surgery, up to 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT to the Breast Then Surgery | Number of Participants With Treatment-related Toxicity | 0 Participants |