Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Breast Cancer Clinical Trial

— APBI  

Official title:

A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01185145
• Other study ID #: WIRB #20040075
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 18, 2010
• Last updated: July 10, 2013
• Start date: February 2004
• Est. completion date: August 2024

Study information

• Verified date: July 2013
• Source: Rocky Mountain Cancer Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 291
• Est. completion date: August 2024
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Breast Brachytherapy with Mammosite RTS
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.
• Intensity Modulated Radiotherapy
Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	Rocky Mountain Cancer Centers - Boulder	Boulder	Colorado
United States	Rocky Mountain Cancer Centers - Midtown	Denver	Colorado
United States	Rocky Mountain Cancer Centers - Littleton	Littleton	Colorado
United States	Rocky Mountain Cancer Centers - Sky Ridge	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers - Thornton	Thornton	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Rocky Mountain Cancer Centers	Charles Leonard, MD

Country where clinical trial is conducted

United States, 

References & Publications (6)

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 — View 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. Epub 2007 Jan 17 — View 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. — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		2-15 years	No
Primary	Disease free survival		2-15 years	No
Primary	Cause specific survival		2-15 years	No
Primary	Ipsilateral breast failure		2-15 years	No
Secondary	Serious Adverse device-related Events		2-5 years	Yes