NCT01185145

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
291

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

10.5 years

First QC Date

August 18, 2010

Last Update Submit

July 10, 2013

Conditions

Breast Cancer

Keywords

breast-conservationaccelerated partial breast irradiationAPBIIMRTIntensity modulated radiotherapybreast brachytherapylumpectomyearly stage breast cancerDCISMammosite

Outcome Measures

Primary Outcomes (4)

  • Overall Survival

    2-15 years

  • Disease free survival

    2-15 years

  • Cause specific survival

    2-15 years

  • Ipsilateral breast failure

    2-15 years

Secondary Outcomes (1)

  • Serious Adverse device-related Events

    2-5 years

Study Arms (2)

Mammosite

EXPERIMENTAL

Accelerated Partial Breast Irradiation using Mammosite RTS

Radiation: Breast Brachytherapy with Mammosite RTS

IMRT

EXPERIMENTAL

Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy

Radiation: Intensity Modulated Radiotherapy

Interventions

Breast Brachytherapy with Mammosite RTSRADIATION

Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.

Also known as: Mammosite, Breast Brachytherapy, Accelerated Partial Breast Irradiation, APBI
Mammosite
Intensity Modulated RadiotherapyRADIATION

Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Also known as: IMRT, APBI, EBRT, Accelerated Partial Breast Irradiation
IMRT

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Be pregnant or breast-feeding
  • Have collagen-vascular disease
  • Inadequate surgical margins (\< 2 mm)
  • Patients with malignant/suspicious calcifications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers - Boulder

Boulder, Colorado, 80303, United States

Location

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, 80128, United States

Location

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, 80120, United States

Location

Rocky Mountain Cancer Centers - Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers - Thornton

Thornton, Colorado, 80260, United States

Location

Related Publications (7)

  • 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.

    PMID: 19467799BACKGROUND

  • 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.

    PMID: 18086392BACKGROUND

  • 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.

    PMID: 23824363RESULT

  • 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.

    PMID: 21665139RESULT

  • 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.

    PMID: 18786783RESULT

  • 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.

    PMID: 17234359RESULT

  • 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.

    PMID: 34469056DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Dennis Carter, MD

    Rocky Mountain Cancer Centers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

February 1, 2004

Primary Completion

August 1, 2014

Study Completion

August 1, 2024

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(6)