Outcomes and Cosmesis With Whole Breast Irradiation and Boost

University of Wisconsin (UW)

Status

Enrolling

Conditions

Early-stage Breast Cancer

Treatments

Radiation: Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06295744

Protocol Version 11/14/2024 (Other Identifier)

A533300 (Other Identifier)

UW23114 (Registry Identifier)

2023-1724

NCI-2024-01891 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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