Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Stereotactic Body Radiation of 21 gy followed by standard of care surgery

Stereotactic Body Radiation to the breast to 21 Gy

Stereotactic Body Radiation SBRT

Jean Wright, MD

Victoria Croog, MD

Antonio C Wolff, MD

Vered Stearns, MD

Fariba Asrari, MD

Ben H Park, MD

Ashley Cimino, MD

Cesar Santa-Maria, MD

Susan Harvey, MD

Karen Smith, MD

Sara Alcorn, MD

Arti Parekh, MD

Andrea Richardson, MD

Pouneh Razavi, MD

Xiaoyan Huang, MD

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

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.

SBRT to the breast follow by standard of care surgery

Study of Stereotactic Radiotherapy for Breast Cancer

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

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.

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.

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.

To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Stereotactic Radiotherapy for Breast Cancer	NCT03043794	Breast Cancer	Stereotactic Bo...	50 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study of Stereotactic Radiotherapy for Breast Cancer	NCT03043794	Breast Cancer	Stereotactic Bo...	50 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for stereotactic body radiation sbrt