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

Breast Cancer Clinical Trial

Official title:

Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05371860
• Other study ID #: IIT2021-10-Giuliano-OmitRT
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2023
• Est. completion date: October 2028

Study information

• Verified date: July 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Other:
• Omit breast radiation
Omit breast radiation for 3 years after surgery

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Armando Giuliano

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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