Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor Positive
HER2/Neu Negative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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)+/...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03359954
Start Date
November 16 2017
End Date
October 31 2027
Last Update
September 29 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030