Clinical trial NCT06295744: Outcomes and Cosmesis With Whole Breast Irradiation and Boost
Official title: Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early-stage Breast Cancer
Keywords: Cosmesis
Simultaneous Integrated Boost
Whole Breast Irradiation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Harvard Breast Cosmesis Scale Score
timeFrame: up to 2 years post-treatment (treatment ends up to 5 weeks on study)
Secondary outcomes:
measure: Change in BREAST-Q Score
timeFrame: 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)
measure: Incidence of Acute Toxicities
timeFrame: up to 90 days post-RT (treatment ends up to 5 weeks on study)
measure: Incidence of Late Toxicities
timeFrame: up to 60 months on study
measure: Ipsilateral Breast Tumor Recurrence-Free Survival
timeFrame: up to 60 months on study
measure: Overall Survival (OS)
timeFrame: up to 60 months on study
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: UW Carbone Cancer Center
name: Jessica Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References: