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

Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; HER2-positive Breast Cancer
• Intervention / Treatment: Other: Omit breast radiation

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omit breast radiation	Other: Omit breast radiation; Omit breast radiation for 3 years after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial	Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.	At time of consent. Assessed up to 3 years

Collaborators and Investigators

• Sponsor: Armando Giuliano
• Investigators: Principal Investigator: Armando Giuliano, MD, FACS, FRCSEd, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; HER2; HER2-positive; sentinel node biopsy; pathologic complete response; lumpectomy; axillary node dissection; partial mastectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IIT2021-10-Giuliano-OmitRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No