Study of Stereotactic Radiotherapy for Breast Cancer

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: Stereotactic Body Radiation Therapy SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03043794

IRB00128074 (Other Identifier)

J1741

Details and patient eligibility

About

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

SBRT to the breast then surgery

Experimental group

Description:

Stereotactic Body Radiation Therapy (SBRT) of 21Gy followed by standard of care surgery

Treatment:

Radiation: Stereotactic Body Radiation Therapy SBRT