Clinical trial · Interventional
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy
A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
NCT01185145CI-TRIAL-00011313APBIunknownPhase 2ClinicalTrials.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)
Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Brachytherapy with Mammosite RTS | Radiation | — | UNRESOLVED |
| Intensity Modulated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mammosite
- description
- Accelerated Partial Breast Irradiation using Mammosite RTS
- interventionNames
- Radiation: Breast Brachytherapy with Mammosite RTS
- type
- EXPERIMENTAL
- label
- IMRT
- description
- Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy
- interventionNames
- Radiation: Intensity Modulated Radiotherapy
Primary outcomes (4)
- measure
- Overall Survival
- timeFrame
- 2-15 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Be a Tis, T1, N0, M0 AJC Classification * Have negative surgical margins (\> or = 2 mm) after final surgery * Should have adequate skin spacing between balloon surface and surface the skin (\> 7 mm)\* * Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease * Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease. Exclusion Criteria: * Be pregnant or breast-feeding * Have collagen-vascular disease * Inadequate surgical margins (\< 2 mm) * Patients with malignant/suspicious calcifications
References
Publications (7)
- BACKGROUNDLeonard CE, Tallhamer M, Johnson T, Hunter K, Howell K, Kercher J, Widener J, Kaske T, Paul D, Sedlacek S, Carter DL. Clinical experience with image-guided radiotherapy in an accelerated partial breast intensity-modulated radiotherapy protocol. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):528-34. doi: 10.1016/j.ijrobp.2009.02.001. Epub 2009 May 19. PMID 19467799
- BACKGROUNDRusthoven KE, Carter DL, Howell K, Kercher JM, Henkenberns P, Hunter KL, Leonard CE. Accelerated partial-breast intensity-modulated radiotherapy results in improved dose distribution when compared with three-dimensional treatment-planning techniques. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):296-302. doi: 10.1016/j.ijrobp.2007.08.047. PMID 18086392
- RESULTLei RY, Leonard CE, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Fryman SP, Kercher JM, Widner JL, Kaske T, Carter DL. Four-year clinical update from a prospective trial of accelerated partial breast intensity-modulated radiotherapy (APBIMRT). Breast Cancer Res Treat. 2013 Jul;140(1):119-33. doi: 10.1007/s10549-013-2623-x. Epub 2013 Jul 4. PMID 23824363
- RESULTLeonard CE, Johnson T, Tallhamer M, Howell K, Kercher J, Kaske T, Barke L, Sedlacek S, Hobart T, Carter DL. Accelerated partial breast intensity-modulated radiotherapy in women who have prior breast augmentation. Clin Breast Cancer. 2011 Jun;11(3):184-90. doi: 10.1016/j.clbc.2011.03.016. Epub 2011 May 4. PMID 21665139
- RESULTReeder R, Carter DL, Howell K, Henkenberns P, Tallhamer M, Johnson T, Kercher J, Widner J, Kaske T, Paul D, Sedlacek S, Leonard CE. Predictors for clinical outcomes after accelerated partial breast intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2009 May 1;74(1):92-7. doi: 10.1016/j.ijrobp.2008.06.1917. Epub 2008 Sep 9. PMID 18786783
- RESULTLeonard C, Carter D, Kercher J, Howell K, Henkenberns P, Tallhamer M, Cornish P, Hunter K, Kondrat J. Prospective trial of accelerated partial breast intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1291-8. doi: 10.1016/j.ijrobp.2006.11.016. Epub 2007 Jan 17.