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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 sites in 1 country40 target enrollmentAugust 1, 2017

ConditionsBreast Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 40
Locations: 2
Primary Endpoint: Treatment Response Measured by Residual Cancer Burden (RCB)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2017

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

Treatment Response Measured by Residual Cancer Burden (RCB)

Time Frame: 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 Outcomes

Number of Participants With Treatment-related Toxicity(RT delivery up to 90 days after completion of surgery, up to 4 months)
Cosmetic Outcome (Patients)(90 days)
Local Recurrence(1 year)
Breast Cancer Treatment Outcomes Scale (BCTOS)(Pre and Post surgery (Up to 3 years))
Cosmetic Outcome (Provider)(90 days)