Breast CancerPhase 1/2CK-SAPBINCT02365714
CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)
A Phase 1/2 study testing CK Stereotactic Accelerated Partial Breast Irradiation in people with Breast Cancer and DCIS, run by Georgetown University at 1 site in United States.
Trial summary
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. Read more about this study
- Who is it for?
- Ages 50 to 99 years, women only
- Conditions the study is for
- Breast Cancer, DCIS, Invasive Ductal Carcinoma
- What is being tested?
- CK Stereotactic Accelerated Partial Breast Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- -Newly diagnosed 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
- ER positive: (≥1% of breast tumor cells express ER in their nuclei)
- PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei)
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- Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) 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 (no cells on ink) and DCIS by at least 1 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
- Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery.
- Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT
- Signed study-specific informed consent form
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 recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
- Patient with lymphovascular space invasion (LVSI).
- Patients with involved axillary nodes.
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- Patients with collagen vascular diseases.
- Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, 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
Georgetown University Hospital
Washington D.C., District of Columbia, 20008
About this study
Official title: A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
Read the detailed description
This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.
- Conditions
- Breast Cancer, DCIS, Invasive Ductal Carcinoma
- Being tested
- CK Stereotactic Accelerated Partial Breast Irradiation
- 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.
CK Stereotactic Accelerated Partial Breast IrradiationRadiation
Also called CyberKnife, SAPBI
Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Radiation | Other | CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days. Receives: Radiation: CK Stereotactic Accelerated Partial Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
Measured: Enrollment to 24 months
Feasibility
How many patients were able to undergo CK SAPBI
Measured: 2 years
Secondary outcomes (1)
Ipsilateral Breast Recurrence
No patients have recurred to date.
Measured: 1 month post radiation treatment through 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonali Rudra, M.D., Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365714
- Sponsor's protocol ID
- CRC012015-02
- Acronym
- CK-SAPBI
- Status last verified
- Jun 2016
- First submitted
- 11 Feb 2015
- Last updated
- 13 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02365714
- Acronym / sponsor ID
- CK-SAPBI / CRC012015-02
- Conditions
- Breast Cancer, DCIS, Invasive Ductal Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 13 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
Detailed description
This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-Radiation | Other | Radiation: CK Stereotactic Accelerated Partial Breast IrradiationCyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- -Newly diagnosed 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
- ER positive: (≥1% of breast tumor cells express ER in their nuclei)
Key exclusion criteria (15 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 recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
- Patient with lymphovascular space invasion (LVSI).
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 Stereotactic Accelerated Partial Breast IrradiationAlso: CyberKnife, SAPBIAdjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days. | Radiation | Treatment-Radiation |
Primary outcome
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
Time frame: Enrollment to 24 months
Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
Feasibility
Time frame: 2 years
How many patients were able to undergo CK SAPBI
1 secondary outcome
Ipsilateral Breast Recurrence
Time frame: 1 month post radiation treatment through 5 years post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sonali Rudra, M.D. principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CK Stereotactic Accelerated Partial Breast Irradiation in people with Breast Cancer and DCIS, 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 15 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: stopped early, as of the sponsor's last update on 13 Apr 2018. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment (time frame: Enrollment to 24 months). The study lists 2 primary outcomes in all. 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 13 Apr 2018; AzTrials last refreshed its copy on 5 Nov 2026.