Breast CancerCKPBINCT01290835
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
A study testing Stereotactic radiotherapy delivered by CyberKnife and stereotactic radiotherapy in people with Breast Cancer, run by Essentia Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Read more about this study
- Who is it for?
- Ages 60 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereotactic radiotherapy delivered by CyberKnife and stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2025
- Phase
- Interventional
- 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 60 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of breast malignancy, stage T1
- Surgical treatment with lumpectomy
- age 60 or older
- resection margins negative by at least 2mm
- any grade
- ER positive
Show all 10Show fewer
- unicentric
- invasive ductal
- pathologic free of nodal metastases (N0, i- or i+)
- Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%
Who cannot join
- Prior radiotherapy to the breast
- Neoadjuvant chemotherapy
- multicentric disease
- Pure DCIS histology
- Presence of extensive intraductal component
- Node positive disease (N1 or greater)
Trial locations and contacts
1 site in 1 country.
United States1 site
Essentia Health SMDC Cancer Center
Duluth, Minnesota, 55805
About this study
The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).
Read the detailed description
This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer
- Conditions
- Breast Cancer
- Being tested
- Stereotactic radiotherapy delivered by CyberKnife, stereotactic radiotherapy
- Keywords
- Stereotactic radiotherapy, CyberKnife following lumpectomy, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapy delivered by CyberKnifeRadiation
Also called CyberKnife
Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.
stereotactic radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiotherapy | Experimental | Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer. Receives: Radiation: Stereotactic radiotherapy delivered by CyberKnife; Radiation: stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treated while also respecting normal tissue tolerances.
Measured: one year
Secondary outcomes (1)
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammography or screening breast MRaI for 5 years.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2025
- Study completionAug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Dornfeld, Essentia Health
- Investigators
- Ken Dornfeld, MD, Principal investigator, Essentia Health Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290835
- Sponsor's protocol ID
- SMDC10101
- Acronym
- CKPBI
- Status last verified
- Aug 2025
- First submitted
- 4 Feb 2011
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Veronesi U, Marubini E, Mariani L, Galimberti V, Luini A, Veronesi P, Salvadori B, Zucali R. Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial. Ann Oncol. 2001 Jul;12(7):997-1003. doi: 10.1023/a:1011136326943.
PubMed 11521809Clark RM, Whelan T, Levine M, Roberts R, Willan A, McCulloch P, Lipa M, Wilkinson RH, Mahoney LJ. Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group. J Natl Cancer Inst. 1996 Nov 20;88(22):1659-64. doi: 10.1093/jnci/88.22.1659.
PubMed 8931610Holli K, Saaristo R, Isola J, Joensuu H, Hakama M. Lumpectomy with or without postoperative radiotherapy for breast cancer with favourable prognostic features: results of a randomized study. Br J Cancer. 2001 Jan;84(2):164-9. doi: 10.1054/bjoc.2000.1571.
PubMed 11161371Liljegren G, Holmberg L, Bergh J, Lindgren A, Tabar L, Nordgren H, Adami HO. 10-Year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial. J Clin Oncol. 1999 Aug;17(8):2326-33. doi: 10.1200/JCO.1999.17.8.2326.
PubMed 10561294Schroen AT, Brenin DR, Kelly MD, Knaus WA, Slingluff CL Jr. Impact of patient distance to radiation therapy on mastectomy use in early-stage breast cancer patients. J Clin Oncol. 2005 Oct 1;23(28):7074-80. doi: 10.1200/JCO.2005.06.032.
PubMed 16192590Benitez PR, Chen PY, Vicini FA, Wallace M, Kestin L, Edmundson G, Gustafson G, Martinez A. Partial breast irradiation in breast conserving therapy by way of intersitial brachytherapy. Am J Surg. 2004 Oct;188(4):355-64. doi: 10.1016/j.amjsurg.2004.06.027.
PubMed 15474426Chen PY, Vicini FA, Benitez P, Kestin LL, Wallace M, Mitchell C, Pettinga J, Martinez AA. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer. 2006 Mar 1;106(5):991-9. doi: 10.1002/cncr.21681.
PubMed 16421922Benitez PR, Keisch ME, Vicini F, Stolier A, Scroggins T, Walker A, White J, Hedberg P, Hebert M, Arthur D, Zannis V, Quiet C, Streeter O, Silverstein M. Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg. 2007 Oct;194(4):456-62. doi: 10.1016/j.amjsurg.2007.06.010.
PubMed 17826055Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
PubMed 19910132Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
PubMed 19395195Dornfeld K, Gessert CE, Renier CM, McNaney DD, Urias RE, Knowles DM, Beauduy JL, Widell SL, McDonald BL. Differences in breast tissue oxygenation following radiotherapy. Radiother Oncol. 2011 Aug;100(2):289-92. doi: 10.1016/j.radonc.2011.02.004. Epub 2011 Feb 26.
PubMed 21356563Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):987-1001. doi: 10.1016/j.ijrobp.2009.02.031.
PubMed 19545784Le QT, Loo BW, Ho A, Cotrutz C, Koong AC, Wakelee H, Kee ST, Constantinescu D, Whyte RI, Donington J. Results of a phase I dose-escalation study using single-fraction stereotactic radiotherapy for lung tumors. J Thorac Oncol. 2006 Oct;1(8):802-9.
PubMed 17409963Rose MA, Olivotto I, Cady B, Koufman C, Osteen R, Silver B, Recht A, Harris JR. Conservative surgery and radiation therapy for early breast cancer. Long-term cosmetic results. Arch Surg. 1989 Feb;124(2):153-7. doi: 10.1001/archsurg.1989.01410020023002.
PubMed 2916935Lovey K, Fodor J, Major T, Szabo E, Orosz Z, Sulyok Z, Janvary L, Frohlich G, Kasler M, Polgar C. Fat necrosis after partial-breast irradiation with brachytherapy or electron irradiation versus standard whole-breast radiotherapy--4-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):724-31. doi: 10.1016/j.ijrobp.2007.03.055. Epub 2007 May 24.
PubMed 17524571
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01290835
- Acronym / sponsor ID
- CKPBI / SMDC10101
- Conditions
- Breast Cancer
- Keywords
- Stereotactic radiotherapy, CyberKnife following lumpectomy, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2025 (actual)
- Study completion
- Aug 2025 (actual)
- First posted
- 7 Feb 2011 (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.
The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).
Detailed description
This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiotherapy | Experimental | Radiation: Stereotactic radiotherapy delivered by CyberKnife, Radiation: stereotactic radiotherapyAccelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer. |
Who may qualify
- Ages
- 60 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Diagnosis of breast malignancy, stage T1
- Surgical treatment with lumpectomy
- age 60 or older
- resection margins negative by at least 2mm
- any grade
Key exclusion criteria (6 listed)
- Prior radiotherapy to the breast
- Neoadjuvant chemotherapy
- multicentric disease
- Pure DCIS histology
- Presence of extensive intraductal component
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 |
|---|---|---|
| Stereotactic radiotherapy delivered by CyberKnifeAlso: CyberKnifeAdjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. | Radiation | Stereotactic radiotherapy |
| stereotactic radiotherapy | Radiation | Stereotactic radiotherapy |
Primary outcome
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
Time frame: one year
Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treated while also respecting normal tissue tolerances.
1 secondary outcome
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 11521809Veronesi U, Marubini E, Mariani L, Galimberti V, Luini A, Veronesi P, Salvadori B, Zucali R. Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial. Ann Oncol. 2001 Jul;12(7):997-1003. doi: 10.1023/a:1011136326943.
- Background: PubMed 8931610Clark RM, Whelan T, Levine M, Roberts R, Willan A, McCulloch P, Lipa M, Wilkinson RH, Mahoney LJ. Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group. J Natl Cancer Inst. 1996 Nov 20;88(22):1659-64. doi: 10.1093/jnci/88.22.1659.
- Background: PubMed 11161371Holli K, Saaristo R, Isola J, Joensuu H, Hakama M. Lumpectomy with or without postoperative radiotherapy for breast cancer with favourable prognostic features: results of a randomized study. Br J Cancer. 2001 Jan;84(2):164-9. doi: 10.1054/bjoc.2000.1571.
- Background: PubMed 10561294Liljegren G, Holmberg L, Bergh J, Lindgren A, Tabar L, Nordgren H, Adami HO. 10-Year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial. J Clin Oncol. 1999 Aug;17(8):2326-33. doi: 10.1200/JCO.1999.17.8.2326.
- Background: PubMed 16192590Schroen AT, Brenin DR, Kelly MD, Knaus WA, Slingluff CL Jr. Impact of patient distance to radiation therapy on mastectomy use in early-stage breast cancer patients. J Clin Oncol. 2005 Oct 1;23(28):7074-80. doi: 10.1200/JCO.2005.06.032.
- Background: PubMed 15474426Benitez PR, Chen PY, Vicini FA, Wallace M, Kestin L, Edmundson G, Gustafson G, Martinez A. Partial breast irradiation in breast conserving therapy by way of intersitial brachytherapy. Am J Surg. 2004 Oct;188(4):355-64. doi: 10.1016/j.amjsurg.2004.06.027.
- Background: PubMed 16421922Chen PY, Vicini FA, Benitez P, Kestin LL, Wallace M, Mitchell C, Pettinga J, Martinez AA. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer. 2006 Mar 1;106(5):991-9. doi: 10.1002/cncr.21681.
- Background: PubMed 17826055Benitez PR, Keisch ME, Vicini F, Stolier A, Scroggins T, Walker A, White J, Hedberg P, Hebert M, Arthur D, Zannis V, Quiet C, Streeter O, Silverstein M. Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg. 2007 Oct;194(4):456-62. doi: 10.1016/j.amjsurg.2007.06.010.
- Background: PubMed 19910132Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
- Background: PubMed 19395195Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
- Background: PubMed 21356563Dornfeld K, Gessert CE, Renier CM, McNaney DD, Urias RE, Knowles DM, Beauduy JL, Widell SL, McDonald BL. Differences in breast tissue oxygenation following radiotherapy. Radiother Oncol. 2011 Aug;100(2):289-92. doi: 10.1016/j.radonc.2011.02.004. Epub 2011 Feb 26.
- Background: PubMed 19545784Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):987-1001. doi: 10.1016/j.ijrobp.2009.02.031.
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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.
Ken Dornfeld, MD principal investigator
Essentia Health Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiotherapy delivered by CyberKnife and stereotactic radiotherapy in people with Breast Cancer, run by Essentia Health at 1 site 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer. (time frame: one year). 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 NCT01290835, which also lists 20 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 15 Aug 2025.