Study of Stereotactic Radiotherapy for Breast Cancer

NCT03043794 | Terminated Phase 2 Results DMC FDA Device

• 2 other identifiers: J1741IRB00128074
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer

Keywords

early stage; low risk

Outcome Measures

Primary Outcomes (1)

• Treatment Response Measured by Residual Cancer Burden (RCB)

  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.

  4-6 weeks

Secondary Outcomes (5)

• Number of Participants With Treatment-related Toxicity

  RT delivery up to 90 days after completion of surgery, up to 4 months

• Cosmetic Outcome (Patients)

  90 days

• Local Recurrence

  1 year

• Breast Cancer Treatment Outcomes Scale (BCTOS)

  Pre and Post surgery (Up to 3 years)

• Cosmetic Outcome (Provider)

  90 days

Study Arms (1)

SBRT to the breast then surgery

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation Therapy SBRT

Interventions

Stereotactic Body Radiation Therapy SBRT RADIATION

Stereotactic Body Radiation Therapy to the breast to 21 Gy

SBRT to the breast then surgery

Eligibility Criteria

• Age: 50 Years - 100 Years
• Gender Eligibility Details: females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Robert L. Sloan Fund for Cancer Research: collaborator

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Study was terminated early, only 4 participants were enrolled. Enrollment was too challenging to continue the study.

Results Point of Contact

• Title: Dana Baker Kaplin, MPH
• Organization: Johns Hopkins University, Department of Radiation Oncology

dkaplin1@jhmi.edu

410-614-3950

Study Officials

• Jean Wright, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SBRT to the breast follow by standard of care surgery

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: August 1, 2017
• Primary Completion: October 20, 2021
• Study Completion: October 22, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)