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

Armando Giuliano

Status and phase

Withdrawn

Phase 2

Conditions

Breast Cancer

HER2-positive Breast Cancer

Treatments

Other: Omit breast radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT05371860

IIT2021-10-Giuliano-OmitRT

Details and patient eligibility

About

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.

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

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