Outcomes and Cosmesis With Whole Breast Irradiation and Boost

Early-stage Breast Cancer Clinical Trial

Official title:

Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295744
• Other study ID #: 2023-1724
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: February 2032

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Cancer Connect
• Phone: 800-622-8922
• Email: clinicaltrials[@]cancer.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2032
• Est. primary completion date: February 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early-stage Breast Cancer

Intervention

Radiation:
• Radiation Therapy
WBI with SIB delivered over 5 fractions

Locations

Country	Name	City	State
United States	UW Carbone Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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.	up to 90 days post-RT (treatment ends up to 5 weeks on study)
Secondary	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	up to 60 months on study
Secondary	Ipsilateral Breast Tumor Recurrence-Free Survival	Kaplan-Meier curves will be used to estimate ipsilateral breast tumor recurrence-free survival.	up to 60 months on study
Secondary	Overall Survival (OS)	Kaplan-Meier curves will be used to estimate OS.	up to 60 months on study