Status:
WITHDRAWN
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
Lead Sponsor:
Armando Giuliano
Conditions:
Breast Cancer
HER2-positive Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast con...
Eligibility Criteria
Inclusion
- Female
- Age ≥ 40 years
- Patients must have a tissue diagnosis of HER2+ breast cancer
- Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy
- Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist
- Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection.
- Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis)
Exclusion
- Breastfeeding
- Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast
- Prior adjuvant radiation therapy
- Patients with diagnosis of inflammatory breast cancer
- Patients with known BRCA mutation or other known breast cancer related deleterious mutations
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05371860
Start Date
July 1 2023
End Date
October 1 2028
Last Update
September 22 2023
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048