Study of Stereotactic Radiotherapy for Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy SBRT

• 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

Arm && Interventions

Group	Intervention	Description
SBRT to the breast then surgery	Stereotactic Body Radiation Therapy SBRT	Stereotactic Body Radiation Therapy (SBRT) of 21Gy followed by standard of care surgery

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