Clinical trial NCT01185145: Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy
Official title: A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast-conservation
accelerated partial breast irradiation
APBI
IMRT
Intensity modulated radiotherapy
breast brachytherapy
lumpectomy
early stage breast cancer
DCIS
Mammosite
Lead sponsor: Rocky Mountain Cancer Centers
Sponsor class: OTHER
Collaborators: name: Charles Leonard, MD
First posted: 2010-08-19
Enrollment: 291
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 2-15 years
measure: Disease free survival
timeFrame: 2-15 years
measure: Cause specific survival
timeFrame: 2-15 years
measure: Ipsilateral breast failure
timeFrame: 2-15 years
Secondary outcomes:
measure: Serious Adverse device-related Events
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers - Boulder
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Midtown
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers - Sky Ridge
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers - Thornton
state: Colorado
Study officials:
affiliation: Rocky Mountain Cancer Centers
name: Dennis Carter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leonard 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.
citation: Rusthoven 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.
citation: Lei 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.
citation: Leonard 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.
citation: Reeder 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.
citation: Leonard 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.
citation: Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002/cam4.4242. Epub 2021 Sep 1.