Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- Estrogen Receptor Positive
- HER2/Neu Negative
- Invasive Breast Carcinoma
- Progesterone Receptor Positive
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03359954
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Simona F Shaitelman M.D. Anderson Cancer Center