Breast NeoplasmsNCT02575612
Diagnosis of Pathological Complete Response by Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer
A study testing vacuum-assisted biopsy in people with Breast Neoplasms, run by Heidelberg University at 1 site in Germany.
Trial summary
The study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- vacuum-assisted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Feb 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigators included patients
- after neoadjuvant chemotherapy (NACT) according to the NACT protocol
- with at least one detectable mass / marker after NACT in ultrasound
- with cT1c-cT4a-c tumors
- after informed consent
- with unilateral or bilateral primary breast cancer, confirmed histologically prior to chemotherapy
Show all 9Show fewer
- with known grading, ER/PgR/HER-2neu- and Ki-67 status
- with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
- clinical / imaging partial or complete response to NACT
Who cannot join
- The investigators excluded patients from the study with
- NACT <12 weeks because of termination due to progressive disease, massive adverse events or patient wish
- non-detectable mass in ultrasound / dislocation of marker (> 10mm distance to the initial lesion)
- cT4d stage (inflammatory breast cancer)
- M1 stages
- stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Breast Unit, Department of Gynecology, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Can a Pathological Complete Response in the Breast be Diagnosed by Vacuum-assisted, Ultrasound Guided Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients? A Proof of Concept From a Prospective Cohort Study
The study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT).
Read the detailed description
Neoadjuvant chemotherapy (NACT) is an increasingly used approach for patients with locally advanced and primarily inoperable breast cancer or for patients with potentially chemosensitive tumors. In clinical routine surgical treatment follows the pre-operative chemotherapy. However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future.
Up to now, prediction of pCR after NACT, i.e. diagnosing a pCR without surgery, is based on tumor biology at diagnosis, the applied NACT regimen and breast imaging results; all with mediocre accuracy. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
From September 1st, 2014 to February 15th, 2015 the investigators performed ultrasound guided vacuum-assisted minimal invasive biopsy (VAB) on 50 breast cancer patients after NACT and directly prior to surgery. To analyse VAB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.
- Conditions
- Breast Neoplasms
- Being tested
- vacuum-assisted biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum-assisted biopsyProcedure or surgery
Also called VAB, vacuum-assisted minimal invasive biopsy
Ultrasound guided VAB was used directly prior to breast conserving surgery or mastectomy. It was performed by experienced physicians (> 50 ultrasound guided minimal invasive biopsies per year, > 500 breast ultrasound examination of the breast per year). The needle was placed below or beside the target lesion according to physician's choice. At least six biopsies should be taken; up to 12 according to the physicians choice. After the VAB a clip marker was placed to highlight the position of the biopsy for specimen radiography and pathology.
| Study group | Role | What they receive |
|---|---|---|
| vacuum-assisted biopy | Experimental | All patients enrolled in this study received a vacuum-assisted biopsy before surgery. Receives: Procedure: vacuum-assisted biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
As an explorative study, the statistical analysis was performed using descriptive methods only.
For a baseline comparison between groups, the investigators compared the group of patients with pCR to the group of patients without pCR. As primary outcomes the investigators calculated negative predictive values (NPV) and false negative rates (FNR) for the whole study cohort as well as for certain subgroups (especially addressing the question of evaluating representativeness of VAB). The investigators calculated two-sided-95% confidence intervals for all results.
Measured: 1 week
Secondary outcomes (1)
negative predictive values to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
As an explorative study, the statistical analysis was performed using descriptive methods only.
For a baseline comparison between groups, the investigators compared the group of patients with pCR to the group of patients without pCR. As primary outcomes the investigators calculated negative predictive values (NPV) and false negative rates (FNR) for the whole study cohort as well as for certain subgroups (especially addressing the question of evaluating representativeness of VAB). The investigators calculated two-sided-95% confidence intervals for all results.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jörg Heil, Heidelberg University
- Investigators
- Joerg Heil, Prof. Dr., Study chair, University of Heidelberg, Department of Gynecology, Breast Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575612
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2019
- First submitted
- 12 Oct 2015
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pfob A, Sidey-Gibbons C, Rauch G, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Degenhardt T, Rom J, Rody A, van Mackelenbergh M, Banys-Paluchowski M, Grosse R, Reinisch M, Karsten M, Golatta M, Heil J. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery. J Clin Oncol. 2022 Jun 10;40(17):1903-1915. doi: 10.1200/JCO.21.02439. Epub 2022 Feb 2.
PubMed 35108029Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8.
PubMed 33307491
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Pathological Complete Response in the Breast be Diagnosed by Vacuum-assisted, Ultrasound Guided Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients? A Proof of Concept From a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02575612
- Acronym / sponsor ID
- 1
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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.
The study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT).
Detailed description
Neoadjuvant chemotherapy (NACT) is an increasingly used approach for patients with locally advanced and primarily inoperable breast cancer or for patients with potentially chemosensitive tumors. In clinical routine surgical treatment follows the pre-operative chemotherapy. However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future.
Up to now, prediction of pCR after NACT, i.e. diagnosing a pCR without surgery, is based on tumor biology at diagnosis, the applied NACT regimen and breast imaging results; all with mediocre accuracy. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
From September 1st, 2014 to February 15th, 2015 the investigators performed ultrasound guided vacuum-assisted minimal invasive biopsy (VAB) on 50 breast cancer patients after NACT and directly prior to surgery. To analyse VAB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vacuum-assisted biopy | Experimental | Procedure: vacuum-assisted biopsyAll patients enrolled in this study received a vacuum-assisted biopsy before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The investigators included patients
- after neoadjuvant chemotherapy (NACT) according to the NACT protocol
- with at least one detectable mass / marker after NACT in ultrasound
- with cT1c-cT4a-c tumors
- after informed consent
Key exclusion criteria (6 listed)
- The investigators excluded patients from the study with
- NACT <12 weeks because of termination due to progressive disease, massive adverse events or patient wish
- non-detectable mass in ultrasound / dislocation of marker (> 10mm distance to the initial lesion)
- cT4d stage (inflammatory breast cancer)
- M1 stages
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 |
|---|---|---|
| vacuum-assisted biopsyAlso: VAB, vacuum-assisted minimal invasive biopsyUltrasound guided VAB was used directly prior to breast conserving surgery or mastectomy. It was performed by experienced physicians (> 50 ultrasound guided minimal invasive biopsies per year, > 500 breast ultrasound examination of the breast per year). The needle was placed below or beside the target lesion according to physician's choice. At least six biopsies should be taken; up to 12 according to the physicians choice. After the VAB a clip marker was placed to highlight the position of the biopsy for specimen radiography and pathology. | Procedure or surgery | vacuum-assisted biopy |
Primary outcome
false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
Time frame: 1 week
As an explorative study, the statistical analysis was performed using descriptive methods only. For a baseline comparison between groups, the investigators compared the group of patients with pCR to the group of patients without pCR. As primary outcomes the investigators calculated negative predictive values (NPV) and false negative rates (FNR) for the whole study cohort as well as for certain subgroups (especially addressing the question of evaluating representativeness of VAB). The investigators calculated two-sided-95% confidence intervals for all results.
1 secondary outcome
negative predictive values to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 35108029Pfob A, Sidey-Gibbons C, Rauch G, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Degenhardt T, Rom J, Rody A, van Mackelenbergh M, Banys-Paluchowski M, Grosse R, Reinisch M, Karsten M, Golatta M, Heil J. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery. J Clin Oncol. 2022 Jun 10;40(17):1903-1915. doi: 10.1200/JCO.21.02439. Epub 2022 Feb 2.
- Derived from this study: PubMed 33307491Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8.
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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.
Joerg Heil, Prof. Dr. study chair
University of Heidelberg, Department of Gynecology, Breast Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vacuum-assisted biopsy in people with Breast Neoplasms, run by Heidelberg University at 1 site in Germany.
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 9 inclusion and 6 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 1 Oct 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups (time frame: 1 week). 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 NCT02575612, which also lists 2 linked publications.
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 1 Oct 2019.