Breast Cancer FemaleNCT03300206

A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

An observational study of Breast Cancer Female, run by Hologic, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System as compared to the current standard-of-care… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Female
What is being tested?: Breast Biopsy
Type of treatment: Medical device
How many people: 525 participants
Where: 7 sitesUnited States
Study dates: 13 Sep 2017to 19 Mar 2019
Phase: Observational
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Female subjects who require a stereotactic breast biopsy procedure.

Who may be able to join

Female aged 18 years of age or older
Subject has at least one breast imaging finding requiring biopsy for which images are available
Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her

Who cannot join

Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

MD Anderson Cancer Center
Houston, Texas, 77030
Kensington Medical Center - Kaiser Permanente
Kensington, Maryland, 29895
HonorHealth
Phoenix, Arizona, 85027
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Elizabeth Wende Breast Center
Rochester, New York, 14620
University of Utah - Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

Conditions: Breast Cancer Female
Being tested: Breast Biopsy
Keywords: Breast Biopsy, Breast Biopsy Imaging, Stereotactic Biopsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breast BiopsyDevice
A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.

Study groups in NCT03300206
Study group	Role	What they receive
Brevera Breast Biopsy System		The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging. Receives: Device: Breast Biopsy
Standard of Care		Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system). Receives: Device: Breast Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Procedural Time in Minutes
The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.
Measured: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.

Secondary outcomes (3)

Post-biopsy Complication Rates
Adverse event percentage rates.
Measured: The time of consent until the subject procedure was completed, an average of 1 day
Number of Samples Collected Per Lesion
Number of samples collected per lesion
Measured: Samples collected from day of Breast Biopsy Procedure Only
Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients
The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).
Measured: Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 201719 Mar 2019

First posted3 Oct 2017
Study start13 Sep 2017
Primary completion19 Mar 2019
Study completion19 Mar 2019

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 Cancer FemaleStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03300206
Sponsor's protocol ID: 16-05B
Status last verified: Oct 2024
First submitted: 25 Sep 2017
Last updated: 4 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
ClinicalTrials.gov ID: NCT03300206
Acronym / sponsor ID: 16-05B
Conditions: Breast Cancer Female
Keywords: Breast Biopsy, Breast Biopsy Imaging, Stereotactic Biopsy
Study type: Observational
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: Hologic, Inc.Industry (pharma, biotech, devices)
Study start: 13 Sep 2017 (actual)
Primary completion: 19 Mar 2019 (actual)
Study completion: 19 Mar 2019 (actual)
First posted: 3 Oct 2017 (actual)
Results: Posted 4 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Brevera Breast Biopsy System	–	Device: Breast BiopsyThe Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging.
Standard of Care	–	Device: Breast BiopsyEach of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Female subjects who require a stereotactic breast biopsy procedure.

Key inclusion criteria (3 listed)

Female aged 18 years of age or older
Subject has at least one breast imaging finding requiring biopsy for which images are available
Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her

Key exclusion criteria (2 listed)

Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.

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
Breast BiopsyA breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.	Device	Brevera Breast Biopsy System, Standard of Care

Primary outcome

Difference in Procedural Time in Minutes
Time frame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.
The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.

3 secondary outcomes

Post-biopsy Complication Rates
Time frame: The time of consent until the subject procedure was completed, an average of 1 day
Number of Samples Collected Per Lesion
Time frame: Samples collected from day of Breast Biopsy Procedure Only
Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only

Results and safety

Results posted to the registry on 4 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brevera Breast Biopsy System	316	316
Standard of Care	209	209

Primary outcome: Difference in Procedural Time in Minutes

Time frame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.. Mean (Standard Deviation). Unit: procedure time in minutes

Measure	Brevera Breast Biopsy System n = 316	Standard of Care n = 209
Value	42.15 (14.06)	40.13 (12.14)

Population analysed: This study involved the participation of 525 female patients aged 18 years or older with suspicious findings on mammographic screening or diagnostic exams who were sent for breast biopsy. These subjects were enrolled at seven different clinical sites (75 subjects per site) and then separated to have their biopsy procedure performed using the current standard of care breast biopsy procedure (209) or the Brevera Breast Biopsy system (316).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 hours: per the standard of care protocol, each subject participating in this study was evaluated for any adverse events from the time the biopsy procedure began to the time the subject was released from the outpatient treatment facility.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brevera Breast Biopsy System	0 of 316 (0%)	9 of 316 (2.8%)	0 of 316
Standard of Care	0 of 209 (0%)	4 of 209 (1.9%)	0 of 209

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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.

The record lists no contact. Use the official record to reach the sponsor.

7 sites 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 Female, run by Hologic, Inc. at 7 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 3 inclusion and 2 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 4 Dec 2024). 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?

Difference in Procedural Time in Minutes (time frame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03300206.

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 Dec 2024.