Phase 1
N=35
Single Dose Partial Breast Radiotherapy
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00944528 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Maximum Tolerated Dose — 21 Gray (Gy)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose |
21 | — |
| SECONDARY Cosmetic Outcome |
71; 100; 100 | — |
| SECONDARY Local Control |
— | — |
Summary
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.
Eligibility Criteria
Inclusion Criteria
- Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
- Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
- Clinical T1N0M0
- 55 years of age or older
- Estrogen receptor (ER) positive,
- No evidence of lymphovascular space invasion on initial biopsy
- Not pregnant. If not post-menopausal must adhere to birth control measures
- White blood cell count > 3000, Hemoglobin > 9, platelets >100000
- Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min
Exclusion Criteria
- Neoadjuvant chemotherapy
- Breast implants
- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
- Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
- HER-2/neu positive
- Positive serum pregnancy test
Data sourced from ClinicalTrials.gov (NCT00944528). 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.