Clinical trial · Interventional
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
NCT06295744CI-TRIAL-00119327active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WBI with SIB
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Harvard Breast Cosmesis Scale Score
- timeFrame
- up to 2 years post-treatment (treatment ends up to 5 weeks on study)
- description
- 4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.
Secondary outcomes (5)
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.