Breast CancerPhase 2APBINCT01185145
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy
A Phase 2 study testing Breast Brachytherapy with Mammosite RTS and Intensity Modulated Radiotherapy in people with Breast Cancer, run by Rocky Mountain Cancer Centers at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Brachytherapy with Mammosite RTS and Intensity Modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2004to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Be pregnant or breast-feeding
- Have collagen-vascular disease
- Inadequate surgical margins (< 2 mm)
- Patients with malignant/suspicious calcifications
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, 80128
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers - Sky Ridge
Lone Tree, Colorado, 80124
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, 80260
About this study
Official title: A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
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
- Breast Cancer
- Being tested
- Breast Brachytherapy with Mammosite RTS, Intensity Modulated Radiotherapy
- Keywords
- breast-conservation, accelerated partial breast irradiation, APBI, IMRT, Intensity modulated radiotherapy, breast brachytherapy, lumpectomy, early stage breast cancer, DCIS, Mammosite
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Brachytherapy with Mammosite RTSRadiation
Also called Mammosite, Breast Brachytherapy, Accelerated Partial Breast Irradiation, APBI
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 RadiotherapyRadiation
Also called IMRT, APBI, EBRT, Accelerated Partial Breast Irradiation
Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation
| Study group | Role | What they receive |
|---|---|---|
| Mammosite | Experimental | Accelerated Partial Breast Irradiation using Mammosite RTS Receives: Radiation: Breast Brachytherapy with Mammosite RTS |
| IMRT | Experimental | Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy Receives: Radiation: Intensity Modulated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 2-15 years
Disease free survival
Measured: 2-15 years
Cause specific survival
Measured: 2-15 years
Ipsilateral breast failure
Measured: 2-15 years
Secondary outcomes (1)
Serious Adverse device-related Events
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startFeb 2004
- Primary completionAug 2014 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Cancer Centers
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Leonard, MD
- Investigators
- Dennis Carter, MD, Principal investigator, Rocky Mountain Cancer Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185145
- Sponsor's protocol ID
- WIRB #20040075
- Acronym
- APBI
- Status last verified
- Jul 2013
- First submitted
- 18 Aug 2010
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19467799Rusthoven 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.
PubMed 18086392Lei 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.
PubMed 23824363Leonard 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.
PubMed 21665139Reeder 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.
PubMed 18786783Leonard 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.
PubMed 17234359Leonard 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.
PubMed 34469056
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
- ClinicalTrials.gov ID
- NCT01185145
- Acronym / sponsor ID
- APBI / WIRB #20040075
- Conditions
- Breast Cancer
- Keywords
- breast-conservation, accelerated partial breast irradiation, APBI, IMRT, Intensity modulated radiotherapy, breast brachytherapy, lumpectomy, early stage breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Rocky Mountain Cancer CentersUniversity, hospital or other
- Collaborators
- Charles Leonard, MD
- Study start
- Feb 2004
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mammosite | Experimental | Radiation: Breast Brachytherapy with Mammosite RTSAccelerated Partial Breast Irradiation using Mammosite RTS |
| IMRT | Experimental | Radiation: Intensity Modulated RadiotherapyAccelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Be pregnant or breast-feeding
- Have collagen-vascular disease
- Inadequate surgical margins (< 2 mm)
- Patients with malignant/suspicious calcifications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Brachytherapy with Mammosite RTSAlso: Mammosite, Breast Brachytherapy, Accelerated Partial Breast Irradiation, APBITreatment 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. | Radiation | Mammosite |
| Intensity Modulated RadiotherapyAlso: IMRT, APBI, EBRT, Accelerated Partial Breast IrradiationAccelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation | Radiation | IMRT |
Primary outcome
Overall Survival
Time frame: 2-15 years
Disease free survival
Time frame: 2-15 years
Cause specific survival
Time frame: 2-15 years
Ipsilateral breast failure
Time frame: 2-15 years
1 secondary outcome
Serious Adverse device-related Events
Time frame: 2-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- Background: PubMed 19467799Leonard 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.
- Background: PubMed 18086392Rusthoven 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 publication: PubMed 23824363Lei 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 publication: PubMed 21665139Leonard 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 publication: PubMed 18786783Reeder 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 publication: PubMed 17234359Leonard 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.
- Derived from this study: PubMed 34469056Leonard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Carter, MD principal investigator
Rocky Mountain Cancer Centers
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Breast Brachytherapy with Mammosite RTS and Intensity Modulated Radiotherapy in people with Breast Cancer, run by Rocky Mountain Cancer Centers at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2-15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185145, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.