Trials / Active Not Recruiting
Active Not RecruitingNCT03359954
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiation Therapy | Undergo radiation therapy |
| PROCEDURE | Therapeutic Conventional Surgery | Undergo breast surgery |
Timeline
- Start date
- 2017-11-16
- Primary completion
- 2027-10-31
- Completion
- 2027-10-31
- First posted
- 2017-12-02
- Last updated
- 2026-03-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03359954. Inclusion in this directory is not an endorsement.