Outcomes and Cosmesis With Whole Breast Irradiation and B... | NCT06295744

Studies
Outcomes and Cosmesis With Whole Breast Irradiation and Boost

NCT06295744

Sponsor

University of Wisconsin, Madison

Status

Recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Early-stage Breast Cancer

Interventions

Radiation Therapy

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

ID	Type	Description
Protocol Version 11/14/2024	Other Identifier	UW Madison
A533300	Other Identifier	UW Madison
UW23114	Registry Identifier	UWCCC OnCore ID
NCI-2024-01891	Registry Identifier	NCI Trial ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2024Actual

Primary Completion Date

Feb 2029Estimated

Completion Date

Feb 2032Estimated

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Feb 28, 2024

First Posted Date

Mar 6, 2024Actual

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

Jun 9, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.

Detailed Description

The study population will consist of 50 participants with non-metastatic, early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). Eligible patients will include those with a biopsy proven invasive breast cancer or DCIS, greater than or equal to 18 years of age, undergoing breast conserving surgery and adjuvant radiation therapy at UW Health with an indication for WBI with tumor bed boost. Selection need for boost and radiation treatment field design and pre-tx imaging are at the discretion of the treating provider.

Accrual will occur over 5 years at UW Health. Participants will complete 5 treatment visits and 7 study visits over the course of approximately 5.5 years. Research-related outcome measures - MD assessments (e.g., cosmesis) PROMs, and AEs -- will be assessed prior to treatment start, at the 6-week follow-up visit, as well as at 12-, 24-, 36-, 48- and 60-month follow-up visits. Study participation ends after completion of the 60-month follow-up visit.

Objective

• To assess two-year cosmetic outcomes in patients treated with ultra-short WBI with a SIB.

Secondary Objectives

To assess PROMs via BREAST-Q in patients treated with ultra-short WBI with SIB.
To assess acute toxicities in patients treated with ultra-short WBI with SIB.
To assess late toxicities in patients treated with ultra-short WBI with SIB.
To assess ipsilateral breast tumor recurrence in patients treated with ultra-short WBI with SIB.
To assess overall survival (OS) in patients treated with ultra-short WBI with SIB.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
WBI with SIB	Experimental		Radiation: Radiation Therapy

Name	Type	Description	Arm Group Labels	Other Names
Radiation Therapy	Radiation	WBI with SIB delivered over 5 fractions	WBI with SIB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Harvard Breast Cosmesis Scale Score	4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.	up to 2 years post-treatment (treatment ends up to 5 weeks on study)

Secondary Outcomes

Measure	Description	Time Frame
Change in BREAST-Q Score	The BREAST-Q questionnaire is scored from 0-100 where higher scores indicate better outcomes in each of 5 domains: Psychosocial Well-Being, Sexual Well-Being, Cancer Worry, Fatigue, and Impact on Work.	baseline, 6 weeks post-RT, 12 months post-RT, 24 months post-RT, 60 months post-RT (treatment ends up to 5 weeks on study)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent document
Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS
Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx
Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques
Treatment plan includes breast tumor bed boost
Willingness to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

Mastectomy of ipsilateral breast
Lack of histologic diagnosis
Histologic involvement of the axillary or regional nodes or metastatic disease
Accelerated partial breast irradiation treatment plan
Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin
Previous history of chest radiation therapy
Previous history of ipsilateral breast cancer
Concurrent cytotoxic chemotherapy
Active connective tissue disease including scleroderma
Inability or unwillingness to return for required follow up visit

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cancer Connect	Contact	800-622-8922		clinicaltrials@cancer.wisc.edu

Overall Officials

Name	Affiliation	Role
Jessica Schuster, MD	UW Carbone Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UW Carbone Cancer Center	Recruiting	Madison	Wisconsin	53792	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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