Health TrialsbyHealthPanel

Outcomes and Cosmesis With Whole Breast Irradiation and Boost

ConditionEarly-stage Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    WBI with SIB delivered over 5 fractions

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: WBI with SIBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Harvard Breast Cosmesis Scale Score

4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.

Time frame
up to 2 years post-treatment (treatment ends up to 5 weeks on study)

Secondary outcomes

1

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.

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)
2

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.

Time frame
up to 90 days post-RT (treatment ends up to 5 weeks on study)
3

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

Time frame
up to 60 months on study
4

Ipsilateral Breast Tumor Recurrence-Free Survival

Kaplan-Meier curves will be used to estimate ipsilateral breast tumor recurrence-free survival.

Time frame
up to 60 months on study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov
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