Study of Stereotactic Radiotherapy for Breast Cancer

NCT ID: NCT03043794

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-10-22

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT to the breast then surgery

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

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy SBRT

Intervention Type: RADIATION

Stereotactic Body Radiation Therapy to the breast to 21 Gy

Interventions

Stereotactic Body Radiation Therapy SBRT

Stereotactic Body Radiation Therapy to the breast to 21 Gy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Robert L. Sloan Fund for Cancer Research

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00128074

Identifier Type: OTHER

Identifier Source: secondary_id

J1741

Identifier Type: -

Identifier Source: org_study_id