Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
NCT ID: NCT03359954
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2017-11-16
2027-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (radiation therapy, surgery)
Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.
Radiation Therapy
Undergo radiation therapy
Therapeutic Conventional Surgery
Undergo breast surgery
Interventions
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Radiation Therapy
Undergo radiation therapy
Therapeutic Conventional Surgery
Undergo breast surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Simona F Shaitelman
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-00993
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0362
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0362
Identifier Type: -
Identifier Source: org_study_id
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