Study of Stereotactic Radiotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03043794
• Other study ID #: J1741
• Secondary ID: IRB00128074
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Jean Wright, MD
• Phone: 202-537-4787
• Email: jwrigh71[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation SBRT
Stereotactic Body Radiation to the breast to 21 Gy

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response	To determine the rate of 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	The rate of treatment-related toxicity	To determine the rate of 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.	90 days
Secondary	The rate of cosmetic outcome	To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 3 years after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images.	90 days
Secondary	The time to recurrence	To measure local recurrence rate	1 year
Secondary	Quality of Life	To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)	1 year