Radiation Omission in Patients With HER2 Overexpressing T... | NCT05371860

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

NCT05371860

Sponsor

Armando Giuliano

Status

Withdrawn

Last Update Posted

Sep 22, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Breast Cancer
HER2-positive Breast Cancer

Interventions

Omit breast radiation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jul 2023Estimated

Primary Completion Date

Oct 2028Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Apr 20, 2022

First Submission Date that Met QC Criteria

May 10, 2022

First Posted Date

May 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2023

Last Update Posted Date

Sep 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omit breast radiation	Experimental		Other: Omit breast radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omit breast radiation	Other	Omit breast radiation for 3 years after surgery	Omit breast radiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armando Giuliano, MD, FACS, FRCSEd	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D000095384	Pathologic Complete Response

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided