Breast Cancer Clinical Trial
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Inclusion:
Age >/=18 years at time of study entry
Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
Presence of a clip in the primary breast cancer
Biopsy-amenable residual disease in the breast measuring >/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Signed written informed consent
Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon.
Exclusion:
Women who are pregnant or breast-feeding
Contraindication to receive radiotherapy
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There is 1 Location for this study
Houston Texas, 77030, United States
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