Clinical trial NCT03043794: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: early stage
low risk
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Robert L. Sloan Fund for Cancer Research
First posted: 2017-02-06
Enrollment: 4
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SBRT to the breast follow by standard of care surgery
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Response Measured by Residual Cancer Burden (RCB)
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Number of Participants With Treatment-related Toxicity
timeFrame: RT delivery up to 90 days after completion of surgery, up to 4 months
measure: Cosmetic Outcome (Patients)
timeFrame: 90 days
measure: Local Recurrence
timeFrame: 1 year
measure: Breast Cancer Treatment Outcomes Scale (BCTOS)
timeFrame: Pre and Post surgery (Up to 3 years)
measure: Cosmetic Outcome (Provider)
timeFrame: 90 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jean Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: