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

NCT ID: NCT05371860

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2028-10-31

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

Conditions

Breast Cancer; HER2-positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omit breast radiation

Group Type: EXPERIMENTAL

Omit breast radiation

Intervention Type: OTHER

Omit breast radiation for 3 years after surgery

Interventions

Omit breast radiation

Omit breast radiation for 3 years after surgery

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Armando Giuliano

OTHER

Sponsor Role: lead

Responsible Party

Armando Giuliano

Chief, Surgical Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Armando Giuliano, MD, FACS, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2021-10-Giuliano-OmitRT

Identifier Type: -

Identifier Source: org_study_id