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Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy (APBI)

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Breast Brachytherapy with Mammosite RTS

Intensity Modulated Radiotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast-conservation, accelerated partial breast irradiation, APBI, IMRT, Intensity modulated radiotherapy, breast brachytherapy, lumpectomy, early stage breast cancer, DCIS, Mammosite

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rocky Mountain Cancer Centers - Aurora
Rocky Mountain Cancer Centers - Boulder
Rocky Mountain Cancer Centers - Midtown
Rocky Mountain Cancer Centers - Littleton
Rocky Mountain Cancer Centers - Sky Ridge
Rocky Mountain Cancer Centers - Thornton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mammosite

IMRT

Arm Description

Accelerated Partial Breast Irradiation using Mammosite RTS

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

Outcomes

Primary Outcome Measures

Overall Survival

Disease free survival

Cause specific survival

Ipsilateral breast failure

Secondary Outcome Measures

Serious Adverse device-related Events

Full Information

NCT ID

NCT01185145

First Posted

August 18, 2010

Last Updated

July 10, 2013

Sponsor

Rocky Mountain Cancer Centers

Collaborators

Charles Leonard, MD

1. Study Identification

Unique Protocol Identification Number

NCT01185145

Brief Title

Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Acronym

APBI

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

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2004 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Rocky Mountain Cancer Centers

Collaborators

Charles Leonard, MD

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast-conservation, accelerated partial breast irradiation, APBI, IMRT, Intensity modulated radiotherapy, breast brachytherapy, lumpectomy, early stage breast cancer, DCIS, Mammosite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

291 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mammosite

Arm Type

Experimental

Arm Description

Accelerated Partial Breast Irradiation using Mammosite RTS

Arm Title

IMRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Breast Brachytherapy with Mammosite RTS

Other Intervention Name(s)

Mammosite, Breast Brachytherapy, Accelerated Partial Breast Irradiation, APBI

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Intensity Modulated Radiotherapy

Other Intervention Name(s)

IMRT, APBI, EBRT, Accelerated Partial Breast Irradiation

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

2-15 years

Title

Disease free survival

Time Frame

2-15 years

Title

Cause specific survival

Time Frame

2-15 years

Title

Ipsilateral breast failure

Time Frame

2-15 years

Secondary Outcome Measure Information:

Title

Serious Adverse device-related Events

Time Frame

2-5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis Carter, MD

Organizational Affiliation

Rocky Mountain Cancer Centers

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rocky Mountain Cancer Centers - Aurora

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Rocky Mountain Cancer Centers - Boulder

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80303

Country

United States

Facility Name

Rocky Mountain Cancer Centers - Midtown

City

Denver

State/Province

Colorado

ZIP/Postal Code

80128

Country

United States

Facility Name

Rocky Mountain Cancer Centers - Littleton

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Rocky Mountain Cancer Centers - Sky Ridge

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80124

Country

United States

Facility Name

Rocky Mountain Cancer Centers - Thornton

City

Thornton

State/Province

Colorado

ZIP/Postal Code

80260

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19467799

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.

Results Reference

background

PubMed Identifier

18086392

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.

Results Reference

background

PubMed Identifier

23824363

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.

Results Reference

result

PubMed Identifier

21665139

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.

Results Reference

result

PubMed Identifier

18786783

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.

Results Reference

result

PubMed Identifier

17234359

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.

Results Reference

result

PubMed Identifier

34469056

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.

Results Reference

derived

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Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

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