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Clinical Trial Summary

This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the change in percent tumor-infiltrating lymphocytes (TIL) as a continuous variable before and after preoperative boost radiotherapy (RT) in hormone receptor (HR)+/human epidermal growth factor receptor2 (HER2)- breast cancers. SECONDARY OBJECTIVES: I. To evaluate the safety of preoperative boost RT administered to patients with HR+/HER2- breast cancer. EXPLORATORY OBJECTIVES: - I. To assess the mechanisms of cell death induced by preoperative boost RT. - II. To assess immunologic and molecular responses to preoperative boost RT. - III. To assess the correlations between immune markers, cell death markers, and their changes during treatment. - IV. To determine if magnetic resonance imaging (MRI) can be used to predict breast tumor response to neoadjuvant radiation. OUTLINE: Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy. After completion of study treatment, patients are followed up at 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03359954
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 16, 2017
Completion date October 31, 2025

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