Omission of Radiation in Patients With Her-2 Positive Breast Cancer

The primary objective of this study is to describe the rate of local control in patients with
her-2 positive early stage breast cancer with a complete response to chemotherapy and
lumpectomy alone.

Eligibility Criteria

Inclusion Criteria:

- Ability to understand and the willingness to sign a written informed consent.

- Karnofsky Performance Status 50% to 100% (Appendix A).

- Women 50 years of age or older with a diagnosis of invasive ductal carcinoma

- Her-2 3+ or FISH ratio of 2.2 or higher, background gene expression with normal copy
number

- Only postmenopausal women will be eligible. Subjects will be classified as being
postmenopausal if they have had:

- No spontaneous menses > 1 year, or

- Bilateral surgical oophorectomy, or

- No menses for < 1 year with FSH and estradiol levels in according to
institutional standards

- cT1-2N0 on clinical staging (verified to have no suspicious axillary or internal
mammary nodes on MRI or ultrasound)

- Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and
plan for completion of one year of trastuzumab

- Patients are required to undergo lumpectomy with sentinel lymph node biopsy

- Pathologic review shows no evidence of residual disease in the tumor bed (to also
include no evidence of residual DCIS)

- Tumor bed should be no larger than 5 cm in size on pathologic review

- Fibrotic area of prior tumor located at least 3 mm away from surgical margins

- No evidence of treatment related change in the lymph nodes on pathologic review

Exclusion Criteria

- Diagnosis of inflammatory breast cancer

- Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin
(unless disease-free for 5 years or more)

- Diagnosis of metastatic disease

Principal Investigator

Melissa Mitchell, MD

Study Contact

Leah Miller 913-588-3670

Estimated Completion Date

Wednesday, July 1, 2020

ClinicalTrials.gov #

NCT03460067
03/08/2018