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

Sponsor

Armando Giuliano (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05371860

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer HER2-positive Breast Cancer	Other: Omit breast radiation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2028

Anticipated Study Completion Date :

May 1, 2028

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Omit breast radiation

Other: Omit breast radiation

Omit breast radiation for 3 years after surgery

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts 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