Back to results

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

Primary Purpose

Breast Cancer, HER2-positive Breast Cancer

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omit breast radiation

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HER2, partial mastectomy, lumpectomy, sentinel node biopsy, axillary node dissection, pathologic complete response, breast cancer, HER2-positive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omit breast radiation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05371860

First Posted

April 20, 2022

Last Updated

September 21, 2023

Sponsor

Armando Giuliano

1. Study Identification

Unique Protocol Identification Number

NCT05371860

Brief Title

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

Official Title

Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Withdrawn

Why Stopped

PI voluntarily closed the study. Will be reopened as a national cooperative group trial.

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

October 2028 (Anticipated)

Study Completion Date

October 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Armando Giuliano

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, HER2-positive Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omit breast radiation

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Omit breast radiation

Intervention Description

Omit breast radiation for 3 years after surgery

Primary Outcome Measure Information:

Title

Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial

Description

Time Frame

At time of consent. Assessed up to 3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Armando Giuliano, MD, FACS, FRCSEd

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs