Description:
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk
breast cancer.
Title
- Brief Title: Study of Stereotactic Radiotherapy for Breast Cancer
- Official Title: A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response
Clinical Trial IDs
- ORG STUDY ID:
J1741
- SECONDARY ID:
IRB00128074
- NCT ID:
NCT03043794
Conditions
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| SBRT to the breast then surgery | Experimental | Stereotactic Body Radiation of 21 gy followed by standard of care surgery | |
Eligibility Criteria
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
| Maximum Eligible Age: | 100 Years |
| Minimum Eligible Age: | 50 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | response |
| Time Frame: | 4-6 weeks |
| Safety Issue: | |
| Description: | To determine the rate of 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 Outcome Measures
| Measure: | The rate of treatment-related toxicity |
| Time Frame: | 90 days |
| Safety Issue: | |
| Description: | To determine the rate of 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. |
| Measure: | The rate of cosmetic outcome |
| Time Frame: | 90 days |
| Safety Issue: | |
| Description: | To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 3 years after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images. |
| Measure: | The time to recurrence |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | To measure local recurrence rate |
| Measure: | Quality of Life |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS) |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Trial Keywords
Last Updated
December 24, 2020
