Breast CancerNCT01961531
BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)
A study testing Accuboost APBI in people with Breast Cancer, run by Brown University at 3 sites in United States.
Trial summary
To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Accuboost APBI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jul 2014to 30 Nov 2021
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed histological diagnosis of invasive breast carcinoma or DCIS;
- Age greater or equal to 50 years old;
- Life expectancy > 6 months;
- Treated by breast conserving surgery
- Pathologic lymph node negative, which includes (pN0 i-, i+);
- Patients, who are at very low risk for sentinel node involvement and sentinel node biopsy is not performed, are eligible if the treating investigator documents clinically lymph node negative (cN0). These patients include:
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- DCIS
- Microinvasion only
- Pure tubular or mucinous histology
- Patients ≥ 70yo with T1a-T1c; estrogen receptor +
- Pathologic tumor size
- less than or equal to 2 cm for invasive disease;
- less than or equal to 3 cm for DCIS;
- Estrogen receptor positive if invasive disease (DCIS can be ER negative)
- Negative surgical margins greater than or equal to 2 mm. A margin of <2mm is acceptable if at natural boundary, i.e. skin or pectoralis fascia.
- No lymphovascular invasion;
- ECOG performance status of 0-2 (Appendix 1);
- Informed consent signed.
Who cannot join
- Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
- Active lupus or scleraderma;
- Pregnancy;
- Psychiatric or addictive disorder that would preclude attending follow-up;
- Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted);
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign);
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- pN+ on axillary dissection or in the sentinel lymph node biopsy (N0i+ are considered node negative and are not excluded);
- Multicentric disease;
- Paget's disease of the nipple;
- Breast Implants
- Distant metastases;
- Lumpectomy cavity not well visualized on AccuBoost imaging;
- Lumpectomy cavity with 1cm margin (CTV/PTV) not adequately encompassed by any available applicator.
- Breast separation with compression > 8cm at time of simulation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCSD Moores Cancer Center
La Jolla, California, 92093
Watson Cancer Center
Lakeland, Florida, 33805
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)
To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.
Read the detailed description
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to accelerated partial breast irradiation (APBI) delivered in a more convenient 5 fraction schedule using non-invasive image-guided breast brachytherapy (NIBB) (AccuBoost System) in women with resected, early stage breast cancer.
Non-invasive image-guided breast brachytherapy (NIBB), using advanced image-guided radiation technology, has the potential to eliminate the disadvantages of the conventional APBI techniques. NIBB facilitates non-invasive partial breast irradiation without the use of catheters or implants. Yet by using breast immobilization and precise image-guidance, it reduces non-target breast tissue within the irradiated field compared with other non-invasive APBI techniques such as 3D-CRT. This has made NIBB an attractive approach to deliver APBI.
We hypothesize that NIBB delivered in 5 treatments will be a more convenient, safe and effective modality to deliver partial breast irradiation.
Anticipated advantages of NIBB protocol treatment include:
- Convenient treatment schedule
- Short course can allow for increased patient access to treatment
- Non-invasive approach
- Increased accuracy with precise targeting of lumpectomy cavity using advanced imaging
- Reduced irradiation of non-target breast tissue
- Reduced skin toxicity
- No heart or lung radiation exposure
- Reduced late skin or breast toxicity
- High rate of good or excellent cosmetic outcome
- High rate of ipsilateral breast tumor control comparable to other APBI techniques
- Conditions
- Breast Cancer
- Being tested
- Accuboost APBI
- Keywords
- DCIS, IDC, Invasive breast carcinoma
- 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.
Accuboost APBIDevice
28Gy delivered in 5 daily fractions
| Study group | Role | What they receive |
|---|---|---|
| Accuboost APBI | Experimental | 28Gy delivered in 5 daily fractions Receives: Device: Accuboost APBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Any Toxicity Related to the Radiation Treatment
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Measured: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years
Secondary outcomes (1)
Number of Participants With Ipsilateral Breast Local Recurrence
Measured: annually for 2 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 posted11 Oct 2013 (estimated)
- Study start24 Jul 2014
- Primary completion26 Oct 2016
- Study completion30 Nov 2021
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 Brown 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Watson Clinic Cancer Center, Cancer Treatment Centers of America, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Jaroslaw Hepel, M.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961531
- Sponsor's protocol ID
- 291
- Status last verified
- Feb 2022
- First submitted
- 10 Oct 2013
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)
- ClinicalTrials.gov ID
- NCT01961531
- Acronym / sponsor ID
- 291
- Conditions
- Breast Cancer
- Keywords
- DCIS, IDC, Invasive breast carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Watson Clinic Cancer Center, Cancer Treatment Centers of America, University of California, San Diego
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 26 Oct 2016 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.
Detailed description
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to accelerated partial breast irradiation (APBI) delivered in a more convenient 5 fraction schedule using non-invasive image-guided breast brachytherapy (NIBB) (AccuBoost System) in women with resected, early stage breast cancer.
Non-invasive image-guided breast brachytherapy (NIBB), using advanced image-guided radiation technology, has the potential to eliminate the disadvantages of the conventional APBI techniques. NIBB facilitates non-invasive partial breast irradiation without the use of catheters or implants. Yet by using breast immobilization and precise image-guidance, it reduces non-target breast tissue within the irradiated field compared with other non-invasive APBI techniques such as 3D-CRT. This has made NIBB an attractive approach to deliver APBI.
We hypothesize that NIBB delivered in 5 treatments will be a more convenient, safe and effective modality to deliver partial breast irradiation.
Anticipated advantages of NIBB protocol treatment include:
- Convenient treatment schedule
- Short course can allow for increased patient access to treatment
- Non-invasive approach
- Increased accuracy with precise targeting of lumpectomy cavity using advanced imaging
- Reduced irradiation of non-target breast tissue
- Reduced skin toxicity
- No heart or lung radiation exposure
- Reduced late skin or breast toxicity
- High rate of good or excellent cosmetic outcome
- High rate of ipsilateral breast tumor control comparable to other APBI techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuboost APBI | Experimental | Device: Accuboost APBI28Gy delivered in 5 daily fractions |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- A confirmed histological diagnosis of invasive breast carcinoma or DCIS;
- Age greater or equal to 50 years old;
- Life expectancy > 6 months;
- Treated by breast conserving surgery
- Pathologic lymph node negative, which includes (pN0 i-, i+);
Key exclusion criteria (14 listed)
- Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
- Active lupus or scleraderma;
- Pregnancy;
- Psychiatric or addictive disorder that would preclude attending follow-up;
- Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted);
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 |
|---|---|---|
| Accuboost APBI28Gy delivered in 5 daily fractions | Device | Accuboost APBI |
Primary outcome
Number of Patients With Any Toxicity Related to the Radiation Treatment
Time frame: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
1 secondary outcome
Number of Participants With Ipsilateral Breast Local Recurrence
Time frame: annually for 2 years post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jaroslaw Hepel, M.D. principal investigator
Brown University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accuboost APBI in people with Breast Cancer, run by Brown University at 3 sites 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 18 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: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 25 Aug 2020). 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?
Number of Patients With Any Toxicity Related to the Radiation Treatment (time frame: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 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 4 Mar 2022.