An observational study in Breast Cancer Female, sponsored by Hologic, Inc.. Completed at 6 sites in 6 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Hologic, Inc. · Observational
Among 1,208 studies in Breast Neoplasms with a site in France — 207 open to participants now, 342 under way, 83 of them phase 3. Breast Neoplasms · France.
Among the 1,208 studies in Breast Neoplasms with a site in France, this one is the 55th largest by enrollment of the 202 observational ones, is one of 49 that started in 2017, is one of 203 observational ones, and was the 680th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 500 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →207 of the 1,208 studies in Breast Neoplasms with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →1,208 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 49 started in 2017.
Median enrollment 150 across the 997 interventional studies, 200 across the 202 observational. Of the 787 that completed or were terminated, 254 (32%) have results posted.
449 of 1,208 have an industry lead sponsor. The 10 most frequent:
Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
Hologic, Inc. has 9 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
81 of the studies in Breast Neoplasms with a site in France that are under way reach primary completion within a year, 19 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04208178Phase 3Novartis PharmaceuticalsStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | 2027-02-26 |
Among the 1,208 studies in Breast Neoplasms with a site in France, from their registry updates:
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.
Any woman who is scheduled for a stereotactic breast biopsy (for possible breast cancer) who meets the inclusion/exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. 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.
Device: 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. 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.
Procedural Time
Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Post-biopsy Complication Rates
Adverse event rates.
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Average Number of Cores Per Lesion
The average number of cores obtained for each lesion across all sites.
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient
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 opinions. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
| Milestone | Brevera Breast Biopsy System |
|---|---|
| Started | 500 |
| Completed | 500 |
| Not completed | 0 |
Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.
| Minutes | Brevera Breast Biopsy System |
|---|---|
| Procedural Time | 38.44 ± 14.17 |
Adverse event rates.
| Participants | Brevera Breast Biopsy System |
|---|---|
| Post-biopsy Complication Rates | 11 |
The average number of cores obtained for each lesion across all sites.
| Cores Per Lesion | Brevera Breast Biopsy System |
|---|---|
| Average Number of Cores Per Lesion | 10.58 (2 to 48) |
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 opinions. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).
| Percentage of procedures | Radiologists' Feedback | Technologists' Feedback | Patients' Feedback |
|---|---|---|---|
| Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient | 76.3 (8.45 to 91.5) | 66.9 (10.1 to 89.9) | 96.8 (0.6 to 99.4) |
Collected over subjects were evaluated for the time the procedure began to the release from the outpatient treatment facility per standard of care for any adverse events that they experienced.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brevera Breast Biopsy System | 0/500 (0%) | 0/500 (0%) | 11/500 (2.2%) |
| Event | Brevera Breast Biopsy System |
|---|---|
| HematomaInjury, poisoning and procedural complications | 9/500 |
| Excessive BleedingInjury, poisoning and procedural complications | 1/500 |
| Dislocation of the marker due to some of the postprocedure haemorrageInjury, poisoning and procedural complications | 1/500 |
| Age, Categorical(Participants) | Brevera Breast Biopsy System |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 500 |
| >=65 years | 0 |
| Age, Continuous(years) | Brevera Breast Biopsy System |
|---|---|
| Mean | 57.4 (33 to 90) |
| Sex: Female, Male(Participants) | Brevera Breast Biopsy System |
|---|---|
| Female | 500 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Brevera Breast Biopsy System |
|---|
| Region of Enrollment(participants) | Brevera Breast Biopsy System |
|---|---|
| Netherlands | 100 |
| United Kingdom | 91 |
| Italy | 100 |
| France | 81 |
| Germany | 28 |
| Spain | 100 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Nov 2018, 12 months.
Results were first posted in Sep 2024, 5 years 9 months after primary completion.
Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 12 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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