Early Stage Breast CancerNCT03946683
Cyberknife for Early Stage Breast Cancer
A study testing Cyberknife for Early Stage Breast Cancer in people with Early Stage Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. Read more about this study
- Who is it for?
- Ages 45 to 45 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Cyberknife for Early Stage Breast Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 23 Apr 2020
- 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 45 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with stage 0, I, or II (Tis, Ti, or T2 <=3cm \& NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion <= 3 cm, treated with wide excision.
- Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
- Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
- No involved axillary lymph nodes by routine histologic examination (H\&E) of sentinel node(s) or of nodes identified from axillary dissection.
- Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment.
Who cannot join
- Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Patients who are pregnant.
- Patients who have any histologically confirmed positive axillary nodes.
- Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less
This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Cyberknife for Early Stage Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberknife for Early Stage Breast CancerRadiation
Also called SBRT (Stereotactic Body Radiation Therapy)
Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Cyberknife for Early Stage Breast Cancer | Experimental | Cyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer. Receives: Radiation: Cyberknife for Early Stage Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate
Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures]
Measured: 1 Year
Secondary outcomes (3)
Complication Rate
Rate of complications or toxicities after Cyberknife body radiosurgery (including skin reactions to radiotherapy and any acute complications or unusual side effects) will be measured via physician's observation and via toxicity reports.
Measured: 1 Year
Score on The Harvard/NSABP/RTOG Breast Cosmesis Scale.
4 Point Scale (I-IV): I. Excellent: When compared with the untreated breast, there is minimal or no difference in the size or shape of the treated breast. II. Good: There is a slight difference in the size or shape of the treated breast as compared with the opposite breast or the original appearance of the treated breast. There may be some mild reddening or darkening of the breast. The thickening or scar tissue III. Fair: Obvious difference in the size and shape of the treated breast. This change involves one-quarter or less of the breast. IV. Poor: Marked change in the appearance of the treated breast involving more than onequarter of the breast tissue. The skin changes may be obvious and detract from the appearance of the breast.
Measured: Baseline, week 10, and week 26
Measure of self reported quality of life using the QOLS
41-item survey can be administered by interviewed in person or over the telephone, and it may also be self-administered by respondents with adequate cognitive functioning. The questions are divided into 5 categories-Material and Physical Well-being, Relationships with other People, Social, Community, and Civic Activities, Personal Development and Fulfillment and Recreation.The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
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 posted13 May 2019
- Study startSep 2010
- Primary completion30 Sep 2014
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan A. Haas, MD, Principal investigator, NYU Winthrop Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946683
- Sponsor's protocol ID
- 18-01721
- Other IDs
- 18-01721
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2015
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less
- ClinicalTrials.gov ID
- NCT03946683
- Acronym / sponsor ID
- 18-01721
- Conditions
- Early Stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 13 May 2019 (actual)
- 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.
This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyberknife for Early Stage Breast Cancer | Experimental | Radiation: Cyberknife for Early Stage Breast CancerCyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer. |
Who may qualify
- Ages
- 45 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with stage 0, I, or II (Tis, Ti, or T2 <=3cm \& NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion <= 3 cm, treated with wide excision.
- Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
- Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
- No involved axillary lymph nodes by routine histologic examination (H\&E) of sentinel node(s) or of nodes identified from axillary dissection.
- Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment.
Key exclusion criteria (5 listed)
- Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Patients who are pregnant.
- Patients who have any histologically confirmed positive axillary nodes.
- Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.
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 |
|---|---|---|
| Cyberknife for Early Stage Breast CancerAlso: SBRT (Stereotactic Body Radiation Therapy)Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer | Radiation | Cyberknife for Early Stage Breast Cancer |
Primary outcome
Local Control Rate
Time frame: 1 Year
Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures]
3 secondary outcomes
Complication Rate
Time frame: 1 Year
Score on The Harvard/NSABP/RTOG Breast Cosmesis Scale.
Time frame: Baseline, week 10, and week 26
Measure of self reported quality of life using the QOLS
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 18 Feb 2021.
- CyberKnife Radiosurgery for Early-Stage Breast CancerLink provided by the sponsor.
- University of Texas Southwestern launches clinical trial for treatment of breast cancer using robotic CyberKnife technologyLink provided by the sponsor.
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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.
Jonathan A. Haas, MD principal investigator
NYU Winthrop Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyberknife for Early Stage Breast Cancer in people with Early Stage Breast Cancer, run by NYU Langone 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 5 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 18 Feb 2021. 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?
Local Control Rate (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.