Breast CancerNCT02457117
A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
An observational study of Breast Cancer, run by Georgetown University at 1 site in United States.
Trial summary
This study is a registry to monitor quality of life and clinical outcomes in patients with clinically localized breast cancer who have received stereotactic accelerated partial breast irradiation via CyberKnife. Read more about this study
- Who is it for?
- Ages 50 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 50 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women receiving breast cancer treatment.
Who may be able to join
- Subjects are eligible to participate in the registry if they receive CK-SAPBI in 5 fractions within 12 weeks of surgery and sign an institution specific consent form.
- Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:
- Newly diagnosed AJCC (seventh edition) Stage 0 or I breast cancer.
- On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
- Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
- Age 50 years or greater
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- ER positive
- PR positive
- Her2 negative (IHC 0-1+; for IHC 2+, FISH must be non-amplified)
- Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
- Negative inked surgical margins of excision or re-excision, clear of invasive tumor and DCIS by at least 2 mm
- Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
- No involved axillary lymph nodes, N0(i+) allowed
- Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT
Who cannot join
- -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- Patients with tumors greater than 2 cm
- Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
- 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. Breast MRI will be required to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
- Patients with involved axillary nodes.
- Patients with collagen vascular diseases (active).
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- Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN, CDH1)
- Patients with prior ipsilateral breast irradiation.
- Patients with prior ipsilateral thoracic irradiation.
- Patients with Paget's disease of the nipple.
- Patients with diffuse suspicious microcalcifications.
- Patients with suspicious microcalcifications remaining on the post-excision mammogram.
- Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
- Patients with oncoplastic reconstruction and absence of surgical clips
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgetown University Hospital
Washington D.C., District of Columbia, 20008
Olusola OBAYOMI-DAVIES, M.D, 202-444-3320, olusola.obayomi-davies@medstar.net
Olusola Obayomi-Davies, M.D
About this study
This study is a registry to monitor quality of life and clinical outcomes in patients with clinically localized breast cancer who have received stereotactic accelerated partial breast irradiation via CyberKnife.
Read the detailed description
Radiotherapy for breast cancer is delivered using several whole breast and partial breast approaches. The optimal approach is unknown. The utilization of partial breast irradiation is growing due to the convenience of fewer fractions versus fifteen- thirty treatments required with conventional or hypofractionated whole breast radiation therapy.
Early results with partial breast techniques are promising, showing similar cancer control and toxicity. There is a large body of mature Phase I/II and preliminary Phase III data available exploring the replacement of WBI with an accelerated course of radiation therapy restricted to the region around the tumor bed (accelerated Partial Breast Irradiation, aPBI) using a variety of techniques. For appropriately selected patients treated with modern techniques, the results are encouraging and the techniques have been shown to be safe, tolerable, and highly reproducible with outcomes similar to WBI.
Currently, there is limited data assessing the quality of life, cosmetic and oncologic outcomes following stereotactic partial breast irradiation in a large patient population. Our study will be the first essential step in aggregating the outcomes of patients undergoing this type of external beam irradiation in a large patient population.
- Conditions
- Breast Cancer
- Being tested
- CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
- Keywords
- CyberKnife, Partial breast irradiation, accelerated partial breast irradiation, breast sbrt
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)Radiation
Also called Breast SBRT, partial breast irradiation
Five fraction radiation therapy to the lumpectomy cavity
What is being measured
The primary outcome is the main question the study is designed to answer.
In breast failure
To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI
Measured: 5 years
Secondary outcomes (4)
Cosmesis
Treatment related Cosmesis based on the Harvard Cosmesis Scale
Measured: 5 years
Regional Recurrence
Regional recurrence free interval defined as time from end of radiation treatment to the diagnosis of disease in the regional lymph nodes
Measured: 5 years
Distant Recurrence
Distant disease free interval defined as the time from end of radiation treatment to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary cancer
Measured: 5 years
Adverse reactions
Toxicity from treatment based on CTCAE version 4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457117
- Sponsor's protocol ID
- 2015-0098
- Status last verified
- Jul 2019
- First submitted
- 27 May 2015
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
- ClinicalTrials.gov ID
- NCT02457117
- Acronym / sponsor ID
- 2015-0098
- Conditions
- Breast Cancer
- Keywords
- CyberKnife, Partial breast irradiation, accelerated partial breast irradiation, breast sbrt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 29 May 2015 (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.
This study is a registry to monitor quality of life and clinical outcomes in patients with clinically localized breast cancer who have received stereotactic accelerated partial breast irradiation via CyberKnife.
Detailed description
Radiotherapy for breast cancer is delivered using several whole breast and partial breast approaches. The optimal approach is unknown. The utilization of partial breast irradiation is growing due to the convenience of fewer fractions versus fifteen- thirty treatments required with conventional or hypofractionated whole breast radiation therapy.
Early results with partial breast techniques are promising, showing similar cancer control and toxicity. There is a large body of mature Phase I/II and preliminary Phase III data available exploring the replacement of WBI with an accelerated course of radiation therapy restricted to the region around the tumor bed (accelerated Partial Breast Irradiation, aPBI) using a variety of techniques. For appropriately selected patients treated with modern techniques, the results are encouraging and the techniques have been shown to be safe, tolerable, and highly reproducible with outcomes similar to WBI.
Currently, there is limited data assessing the quality of life, cosmetic and oncologic outcomes following stereotactic partial breast irradiation in a large patient population. Our study will be the first essential step in aggregating the outcomes of patients undergoing this type of external beam irradiation in a large patient population.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 50 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women receiving breast cancer treatment.
Key inclusion criteria (14 listed)
- Subjects are eligible to participate in the registry if they receive CK-SAPBI in 5 fractions within 12 weeks of surgery and sign an institution specific consent form.
- Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:
- Newly diagnosed AJCC (seventh edition) Stage 0 or I breast cancer.
- On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
- Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
Key exclusion criteria (14 listed)
- -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- Patients with tumors greater than 2 cm
- Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
- 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. Breast MRI will be required to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
- Patients with involved axillary nodes.
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 Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)Also: Breast SBRT, partial breast irradiationFive fraction radiation therapy to the lumpectomy cavity | Radiation | – |
Primary outcome
In breast failure
Time frame: 5 years
To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI
4 secondary outcomes
Cosmesis
Time frame: 5 years
Regional Recurrence
Time frame: 5 years
Distant Recurrence
Time frame: 5 years
Adverse reactions
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Georgetown University 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 14 inclusion and 14 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 17 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olusola Obayomi-Davies, M.D. (6104465860, olusola.obayomi-davies@crozer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In breast failure (time frame: 5 years). 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 17 Jul 2019.