Breast Cancer Clinical Trial

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Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response

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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 conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

25

Study ID:

NCT05371860

Recruitment Status:

Not yet recruiting

Sponsor:

Armando Giuliano

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There is 1 Location for this study

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Cedars-Sinai Medical Center
Los Angeles California, 90048, United States More Info
Parisa Mirzadehgan, MS, MHDS
Contact
310-967-4387
[email protected]
Armando Giuliano, MD, FACS, FRCSEd
Principal Investigator
Alice Chung, MD
Sub-Investigator
Catherine Dang, MD
Sub-Investigator
Farin Amersi, MD
Sub-Investigator
Scott Karlan, MD
Sub-Investigator
Reva Basho, MD
Sub-Investigator
Monica Mita, MD
Sub-Investigator
C. Michele Burnison, MD
Sub-Investigator
Stephen Shiao, MD, PhD
Sub-Investigator
Philomena McAndrew, MD
Sub-Investigator
Dorothy Park, MD
Sub-Investigator
Maryliza El-Masry, MD
Sub-Investigator
Nimmi Kapoor, MD
Sub-Investigator
Cathie T Chung, MD
Sub-Investigator
Ashley Marumoto, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

25

Study ID:

NCT05371860

Recruitment Status:

Not yet recruiting

Sponsor:


Armando Giuliano

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
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