Early-stage Breast CancerNCT06295744
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
A study testing Radiation Therapy in people with Early-stage Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
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.
Read the 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.
- Conditions
- Early-stage Breast Cancer
- Being tested
- Radiation Therapy
- Keywords
- Cosmesis, Simultaneous Integrated Boost, Whole Breast Irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
WBI with SIB delivered over 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| WBI with SIB | Experimental | Not described Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvard Breast Cosmesis Scale Score
4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.
Measured: up to 2 years post-treatment (treatment ends up to 5 weeks on study)
Secondary outcomes (5)
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.
Measured: 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)
Incidence of Acute Toxicities
Acute toxicities (including breast dermatitis, induration) will be assessed after final treatment within 90 days of radiation therapy completion using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: up to 90 days post-RT (treatment ends up to 5 weeks on study)
Incidence of Late Toxicities
Late toxicities (including induration, fibrosis, shrinkage, and telangiectasia) will be assessed greater than 90 days of radiation therapy completion using CTCAE version 5.0
Measured: up to 60 months on study
Ipsilateral Breast Tumor Recurrence-Free Survival
Kaplan-Meier curves will be used to estimate ipsilateral breast tumor recurrence-free survival.
Measured: up to 60 months on study
Overall Survival (OS)
Kaplan-Meier curves will be used to estimate OS.
Measured: up to 60 months on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start17 Apr 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Schuster, MD, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295744
- Sponsor's protocol ID
- 2023-1724
- Other IDs
- Protocol Version 11/14/2024, A533300, UW23114, NCI-2024-01891
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
- ClinicalTrials.gov ID
- NCT06295744
- Acronym / sponsor ID
- 2023-1724
- Conditions
- Early-stage Breast Cancer
- Keywords
- Cosmesis, Simultaneous Integrated Boost, Whole Breast Irradiation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WBI with SIB | Experimental | Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyWBI with SIB delivered over 5 fractions | Radiation | WBI with SIB |
Primary outcome
Harvard Breast Cosmesis Scale Score
Time frame: up to 2 years post-treatment (treatment ends up to 5 weeks on study)
4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.
5 secondary outcomes
Change in BREAST-Q Score
Time frame: 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)
Incidence of Acute Toxicities
Time frame: up to 90 days post-RT (treatment ends up to 5 weeks on study)
Incidence of Late Toxicities
Time frame: up to 60 months on study
Ipsilateral Breast Tumor Recurrence-Free Survival
Time frame: up to 60 months on study
Overall Survival (OS)
Time frame: up to 60 months on study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Schuster, MD principal investigator
UW Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Early-stage Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard Breast Cosmesis Scale Score (time frame: up to 2 years post-treatment (treatment ends up to 5 weeks on study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.