Phase 2
Completed N=166
A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca
Source: ClinicalTrials.gov NCT02453737 ↗Enrolled (actual)
166
Serious AEs
0.6%
Results posted
Aug 2023
Primary outcomePrimary: Change in the Rate of Adverse Cosmesis (Defined as Fair or Poor Cosmesis) Compared to Baseline Using the Harvard Cosmetic Rating: — 2; 0; 0 Participants
Summary
This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Rate of Adverse Cosmesis (Defined as Fair or Poor Cosmesis) Compared to Baseline Using the Harvard Cosmetic Rating: |
2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Female Age ≥ 50 years at diagnosis
- Grade 1-3 invasive ductal, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring ≤ 2cm (clinical stage T1).
- Estrogen Receptor (ER)+ (ER- DCIS meeting other eligibility criteria are eligible)
- Unicentric: Patients with microscopic multifocality are eligible as long as the total pathologic tumor size is 1 quadrant) suspicious calcifications
- Histologic evidence of angiolympatic invasion (ALI). Note: Cases termed focally suspicious for ALI but where no definitive ALI is found are eligible.
- Surgical margins that cannot be microscopically assessed or that are positive
- Pathologic tumor >2cm in size
- Metastatic disease
- Patients for whom the delivery of APBI is not feasible or any of the dosimetric treatment criteria in section 9.7 have not been met.
- BRCA 1/2 mutation Note: Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. However, in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study.
- Breast implants (patients who have had implants removed are eligible).
- Extensive intraductal component
- Active connective tissue disease
- Reduction mammoplasty if 3DCRT or proton APBI are planned
- Last surgery >10 weeks from enrollment
Data sourced from ClinicalTrials.gov (NCT02453737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.