Study of Stereotactic Radiotherapy for Breast Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03043794

Patient View

This Phase II trial evaluates preoperative SBRT for hormone-receptor positive early-stage breast cancer, focusing on pathologic response, toxicity, and quality of life. Eligible participants are post-menopausal women aged 50+, with T1 invasive ductal carcinoma, node-negative, and planning breast-conserving surgery. Exclusions include certain medical conditions and prior therapies.

Patient Parameters

Program Overview

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

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

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