Breast Cancer351NCT03437915
BrUOG 351: PRE-OPERATIVE APBI USING NIBB
A study testing NIBB: accuboost and Partial mastectomy in people with Breast Cancer and Invasive Breast Cancer, run by Jaroslaw Hepel.
Trial summary
Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer, Ductal Carcinoma in Situ
- What is being tested?
- NIBB: accuboost and Partial mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to 21 Jan 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed histological diagnosis of invasive breast carcinoma and/or DCIS (Invasive lobular carcinoma excluded);
- Age greater or equal to 60 years old;
- Life expectancy > 6 months;
- Candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon
- Clinically lymph node negative (cN0) as confirmed in writing by patient's treating physician. If patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cN0.
- Tumor size by imaging ≤ 2cm; (Tis or T1)
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- Estrogen receptor positive if invasive disease (DCIS can be ER negative);
- Her2neu negative if invasive disease;
- Nuclear Grade 1 or 2 if invasive disease (DCIS can be Grade 3);
- ECOG performance status of 0-2 (Appendix 1);
- Informed consent signed.
Who cannot join
- Excisional biopsy or ipsilateral breast surgery within 6 months;
- Invasive lobular histology;
- Definitive LVSI on biopsy;
- Suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign;
- Paget's disease of the nipple
- Distant metastases;
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- Known BRCA 1/2 Mutation
- Active lupus or scleroderma,;
- Psychiatric or addictive disorder that would preclude attending follow-up;
- Neoadjuvant chemotherapy or endocrine therapy (adjuvant therapy is permitted);
- Breast Implants;
- Tumor not well visualized on AccuBoost imaging;
- Breast separation with compression > 8cm at time of simulation.
About this study
Official title: BrUOG 351: Pre-Operative Accelerated Partial Breast Irradiation (APBI) Using Non-Invasive Image-Guided Breast Brachytherapy (NIBB)
Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.
In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.
- Being tested
- NIBB: accuboost, Partial mastectomy
- 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.
NIBB: accuboostRadiation
28.5 Gy delivered in 5 daily fractions
Partial mastectomyProcedure or surgery
4-12 weeks post NIBB
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 28.5 Gy delivered in 5 daily fractions then 4-12 weeks post NIBB, surgery via partial mastectomy Receives: Radiation: NIBB: accuboost; Procedure: Partial mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of APBI including rate of surgical complications.
Measured: Surgery will occur 4-12 weeks post NIBB treatment
Toxicity of pre-op APBI including rate of surgical complications.
Defined as acute (during treatment and through 4 weeks post treatment)
Measured: Defined at up to 6 weeks post APBI
Toxicity of surgical complications
Measured: Surgery to occur 4-12 weeks post radiation and post-op complications collected through 3 months post surgery
Secondary outcomes (1)
Assess and report late toxicity
Late toxicity defined as 6 weeks post NIBB through 3 years in follow-up
Measured: 6 weeks post treatment through 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startMar 2019 (estimated)
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Why it stopped: Secondary to medicare coverage determination
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaroslaw Hepel
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island
- Responsible party
- Sponsor-investigator, Jaroslaw Hepel, Brown University
- Investigators
- Jaroslaw Hepel, MD, Principal investigator, Rhode Island Hospital/ BrUOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437915
- Sponsor's protocol ID
- BrUOG 351
- Acronym
- 351
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG 351: Pre-Operative Accelerated Partial Breast Irradiation (APBI) Using Non-Invasive Image-Guided Breast Brachytherapy (NIBB)
- ClinicalTrials.gov ID
- NCT03437915
- Acronym / sponsor ID
- 351 / BrUOG 351
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Secondary to medicare coverage determination
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jaroslaw HepelUniversity, hospital or other
- Collaborators
- Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island
- Study start
- Mar 2019 (estimated)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 19 Feb 2018 (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.
Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.
In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: NIBB: accuboost, Procedure: Partial mastectomy28.5 Gy delivered in 5 daily fractions then 4-12 weeks post NIBB, surgery via partial mastectomy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed histological diagnosis of invasive breast carcinoma and/or DCIS (Invasive lobular carcinoma excluded);
- Age greater or equal to 60 years old;
- Life expectancy > 6 months;
- Candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon
- Clinically lymph node negative (cN0) as confirmed in writing by patient's treating physician. If patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cN0.
Key exclusion criteria (13 listed)
- Excisional biopsy or ipsilateral breast surgery within 6 months;
- Invasive lobular histology;
- Definitive LVSI on biopsy;
- Suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign;
- Paget's disease of the nipple
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 |
|---|---|---|
| NIBB: accuboost28.5 Gy delivered in 5 daily fractions | Radiation | Treatment Arm |
| Partial mastectomy4-12 weeks post NIBB | Procedure or surgery | Treatment Arm |
Primary outcome
Feasibility of APBI including rate of surgical complications.
Time frame: Surgery will occur 4-12 weeks post NIBB treatment
Toxicity of pre-op APBI including rate of surgical complications.
Time frame: Defined at up to 6 weeks post APBI
Defined as acute (during treatment and through 4 weeks post treatment)
Toxicity of surgical complications
Time frame: Surgery to occur 4-12 weeks post radiation and post-op complications collected through 3 months post surgery
1 secondary outcome
Assess and report late toxicity
Time frame: 6 weeks post treatment through 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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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, MD principal investigator
Rhode Island Hospital/ BrUOG
Questions about this trial
What is this clinical trial studying?
A study testing NIBB: accuboost and Partial mastectomy in people with Breast Cancer and Invasive Breast Cancer, run by Jaroslaw Hepel.
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 11 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of APBI including rate of surgical complications. (time frame: Surgery will occur 4-12 weeks post NIBB treatment). The study lists 3 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 9 Mar 2021.