Study of Stereotactic Radiotherapy for Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT03043794
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-06
• Study Start: 2017-08-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States