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

NCT05371860 | Withdrawn Phase 2 DMC

• 1 other identifier: IIT2021-10-Giuliano-OmitRT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

HER2; partial mastectomy; lumpectomy; sentinel node biopsy; axillary node dissection; pathologic complete response; breast cancer; HER2-positive

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Omit breast radiation

EXPERIMENTAL

Other: Omit breast radiation

Interventions

Omit breast radiation OTHER

Omit breast radiation for 3 years after surgery

Omit breast radiation

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Armando Giuliano: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Armando Giuliano, MD, FACS, FRCSEd

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Surgical Oncology

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 12, 2022
• Study Start: July 1, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 22, 2023

Record last verified: 2023-07

Locations

US (1)