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

Phase 2

Withdrawn

• Conditions: Breast Cancer; HER2-positive Breast Cancer
• Interventions: Other: Omit breast radiation

• Registration Number: NCT05371860
• Lead Sponsor: Armando Giuliano

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-12
• Status Verified: 2023-07
• Study Start: 2023-07
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omit breast radiation	Omit breast radiation	-

Primary Outcome Measures

Name	Time	Method
Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial	At time of consent. Assessed up to 3 years	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States