Breast CancerCYBERBOOSTNCT02867423
Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation After Conventional Breast Radiation.
A study testing CK Boost radiation in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CK Boost radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jul 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unifocal breast cancer histologically proven
- Age> 18 years old, in good general condition (ECOG 0-2)
- No cons-indication for radiotherapy
- Patient who underwent lumpectomy and axillary dissection or sentinel node technique.
- carcinoma histology ductal or lobular carcinoma
- surgical margins microscopically without residual disease (> 1 mm)
- tumors classes T1 or T2, N0
Who cannot join
- residual calcifications on X-ray examination
- Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular
- multifocal breast Cancer
- prior Breast radiotherapy
- Patient who received chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.
CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.
Read more
The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.
The results, in terms of local control, will be evaluated on clinical monitoring.
- Conditions
- Breast Cancer
- Being tested
- CK Boost radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK Boost radiationDevice
single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation
| Study group | Role | What they receive |
|---|---|---|
| A - CK boost radiation | Other | CK boost radiation Receives: Device: CK Boost radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC score for erythema, telangiectasia, edema, pain
early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startFeb 2011
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Yves BONDIAU, md, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867423
- Sponsor's protocol ID
- 2009/01 CYBERBOOST
- Other IDs
- 2010-A00284-35
- Acronym
- CYBERBOOST
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2016
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bondiau PY, Gal J, Chapellier C, Haudebourg J, Courdi A, Levy J, Gerard A, Sumodhee S, Maurin M, Chateau Y, Barranger E, Ferrero JM, Thariat J. Robotic Stereotactic Boost in Early Breast Cancer, a Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):374-380. doi: 10.1016/j.ijrobp.2018.09.020. Epub 2018 Oct 26.
PubMed 30612961
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.
- ClinicalTrials.gov ID
- NCT02867423
- Acronym / sponsor ID
- CYBERBOOST / 2009/01 CYBERBOOST
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 Aug 2016 (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 CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.
CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.
The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.
The results, in terms of local control, will be evaluated on clinical monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A - CK boost radiation | Other | Device: CK Boost radiationCK boost radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- unifocal breast cancer histologically proven
- Age> 18 years old, in good general condition (ECOG 0-2)
- No cons-indication for radiotherapy
- Patient who underwent lumpectomy and axillary dissection or sentinel node technique.
- carcinoma histology ductal or lobular carcinoma
Key exclusion criteria (5 listed)
- residual calcifications on X-ray examination
- Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular
- multifocal breast Cancer
- prior Breast radiotherapy
- Patient who received chemotherapy
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 |
|---|---|---|
| CK Boost radiationsingle dose of 8 Grays is issued by the CK to the 6th week after conventional radiation | Device | A - CK boost radiation |
Primary outcome
EORTC score for erythema, telangiectasia, edema, pain
Time frame: 2 months
early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.
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 23 Apr 2026.
- Results publication: PubMed 30612961Bondiau PY, Gal J, Chapellier C, Haudebourg J, Courdi A, Levy J, Gerard A, Sumodhee S, Maurin M, Chateau Y, Barranger E, Ferrero JM, Thariat J. Robotic Stereotactic Boost in Early Breast Cancer, a Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):374-380. doi: 10.1016/j.ijrobp.2018.09.020. Epub 2018 Oct 26.
- Individual participant dataSharing planned: Undecided
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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.
Pierre Yves BONDIAU, md principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CK Boost radiation in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
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 7 inclusion and 5 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 23 Apr 2026. 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 France. 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?
EORTC score for erythema, telangiectasia, edema, pain (time frame: 2 months). 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 NCT02867423, which also lists 1 linked publication.
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 23 Apr 2026.