Breast CancerNCT02031042
Sentinel Node Biopsy Before and/or After Neoadjuvant Chemotherapy in Breast Cancer
An observational study of Breast Cancer, run by Stockholm South General Hospital at 20 sites in Sweden.
Trial summary
The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the sentinel lymph node is free of metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 224 participants
- Where
- 20 sitesSweden
- Study dates
- Oct 2010to Dec 2015
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically verified breast cancer planned for neoadjuvant chemotherapy
Who may be able to join
- clinically node-negative (or unclear nodal status) substudy I
- signed consent from the study participant
Who cannot join
- inflammatory breast cancer
- cytologically verified lymph node metastasis/es at diagnosis (substudy I), but these patients can be included in substudy II
- patients not able to give an informed consent
- hypersensitivity or allergy against blue dye or isotope
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Sweden20 sites
Falu lasarett
Falun, 791 85
Sahlgrenska Universitetssjukhuset, Sahlgrenska
Gothenburg, 413 45
Länssjukhuset i Halmstad
Halmstad, 301 85
Helsingborgs lasarett
Helsingborg, 251 87
Blekingesjukhuset Karlskrona
Karlskrona, 371 81
Centralsjukhuset i Karlstad
Karlstad, 651 85
Centralsjukhuset i Kristianstad
Kristianstad, 291 85
Universitetssjukhuset i Linköping
Linköping, 581 85
Skånes Universitetssjukhus, Lund
Lund, 221 85
Skånes Universitetssjukhus, Malmö
Malmö, 205 02
Universitetssjukhuset i Örebro
Örebro, 701 85
Capio St Görans Sjukhus
Stockholm, 112 81
Södersjukhuset/Stockholm South General Hospital
Stockholm, 118 83
Karolinska Universitetssjukhuset i Solna
Stockholm, 171 76
Länssjukhuset Sundsvall-Härnösand
Sundsvall, 851 86
NU-sjukvården, Uddevalla sjukhus
Uddevalla, 451 80
Norrlands Universitetssjukhus
Umeå, 901 85
Akademiska sjukhuset i Uppsala
Uppsala, 751 85
Centrallasarettet i Västerås
Västerås, 721 89
Centrallasaretttet i Växjö
Vaxjo, 351 85
About this study
The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the sentinel lymph node is free of metastasis.
Read the detailed description
Sentinel lymph node biopsy (SLNB) was introduced in the late 1990´s and has become standard procedure for staging of the axilla in early stage breast cancer associated with significantly less arm morbidity than axillary lymph node dissection (ALND).
Neoadjuvant chemotherapy (NAC) given before breast surgery is indicated for locally advanced breast cancer but is increasingly used for early stage breast cancer with the purpose of downstaging the tumor and thereby possibly enabling breast conserving surgery. Traditionally, the standard axillary staging tool has been ALND although up to 50 per cent of the patients at diagnosis do not have any metastases in their axillary lymph nodes. In addition, NAC can eradicate metastases in the axillary lymph nodes in up to 40 per cent of the patients.
SLNB has therefore been evaluated in the neoadjuvant setting both before and after NAC but is still controversial and the timing debated.
This is a Swedish prospective multi-institutional study without any comparison goup. The comparison is between the findings in the SLNB and the following ALND performed after NAC in all patients.
If the patient is clinically node-negative at diagnosis a SLNB is performed before (without frozen section) and after NAC (substudy I). The reasons for repeating SLNB both before and after NAC are 1) to find out what happens during NAC 2) if it is possible to identify a repeat SLNB and 3) if it is reliable.
If the patient is node-positive at diagnosis (cytologically verified lymph node metastasis) SLNB is performed after NAC together with the breast operation and ALND (substudy II). When SLNB is performed after NAC, the sentinel lymph nodes are also analysed with frozen section in order to validate the method after chemotherapy. Both blue dye and radiolabelled isotope for localisation of the sentinel lymph node is recommended but lymphoscintigraphy is optional.
All consecutive clinically node-negative (or with unclear nodal status after ultrasound and cytology) patients planned for NAC will have oral and written information about the study by the responsible surgeon. After accepting to participate, the patient is asked to sign a written consent. Patients with a cytologically verified lymph node metastasis/es at diagnosis will be informed and asked to participate in substudy II after completion of NAC.
According to the statistical analysis, and with an expected loss of 10 per cent, a sample size of 220 patients is needed in substudy I to show that the false negative rate is less than 10 per cent. If we include 200 patients and 50 per cent are lymph node positive at diagnosis then the estimation of false negative rate will be based on 100 individuals. If we estimate the true false negative rate to be 8 per cent, then the precision with 80 per cent power will be +/- 7 per cent units (2-sided test with 95 per cent confidence interval).
The Central Contact (PI) is responsible for data collection, management and analysis. Each protocol will be sent together with a written consent and copies of all relevant histopathological reports to the PI, who will control for missing or incongruent data and if so, ask the responsible investigator on that institution/hospital to complement the missing data from the patients journal (copies of medical records or histopathological reports).
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant chemotherapy, breast cancer, sentinel lymph node biopsy, false negative rate, identification rate
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate
The rate of patients with no metastasis/ses in their sentinel lymph node/s before neoadjuvant chemotherapy (NAC) but metastasis/ses in the nodes from the axillary lymph node dissection performed after NAC will be analysed. In substudy II we also investigate the false negative rate in sentinel lymph node biopsies performed after NAC if the patient had positive lymph nodes at diagnosis.
Measured: Up to two years
Secondary outcomes (1)
Identification rate
The number of successful sentinel lymph node biopsies among the total number of attempted biopsies. Will be analyses both before and after neoadjuvant chemotherapy.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Breast Cancer Group
- Responsible party
- Principal investigator, Linda Zetterlund, Stockholm South General Hospital
- Investigators
- Linda H Zetterlund, PhD, Principal investigator, Dep. of Medical Research and Education, Karolinska Institutet (KI), Stockholm, SwedenFuat Celebioglu, PhD, Study chair, Dep. of Medical Research and Education, KI, Stockholm, SwedenJan Frisell, Professor, Study chair, Dep. of Molecular Medicine and Surgery, KI, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031042
- Sponsor's protocol ID
- 2010/441-31/4
- Status last verified
- Oct 2019
- First submitted
- 19 Dec 2013
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kuerer HM, Sahin AA, Hunt KK, Newman LA, Breslin TM, Ames FC, Ross MI, Buzdar AU, Hortobagyi GN, Singletary SE. Incidence and impact of documented eradication of breast cancer axillary lymph node metastases before surgery in patients treated with neoadjuvant chemotherapy. Ann Surg. 1999 Jul;230(1):72-8. doi: 10.1097/00000658-199907000-00011.
PubMed 10400039Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
PubMed 14559892Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
PubMed 15837984Xing Y, Foy M, Cox DD, Kuerer HM, Hunt KK, Cormier JN. Meta-analysis of sentinel lymph node biopsy after preoperative chemotherapy in patients with breast cancer. Br J Surg. 2006 May;93(5):539-46. doi: 10.1002/bjs.5209.
PubMed 16329089Schrenk P, Hochreiner G, Fridrik M, Wayand W. Sentinel node biopsy performed before preoperative chemotherapy for axillary lymph node staging in breast cancer. Breast J. 2003 Jul-Aug;9(4):282-7. doi: 10.1046/j.1524-4741.2003.09406.x.
PubMed 12846861Papa MZ, Zippel D, Kaufman B, Shimon-Paluch S, Yosepovich A, Oberman B, Sadetzki S. Timing of sentinel lymph node biopsy in patients receiving neoadjuvant chemotherapy for breast cancer. J Surg Oncol. 2008 Nov 1;98(6):403-6. doi: 10.1002/jso.21128.
PubMed 18683193Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
PubMed 23683750Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.
PubMed 24101169Zetterlund L, Celebioglu F, Axelsson R, de Boniface J, Frisell J. Swedish prospective multicenter trial on the accuracy and clinical relevance of sentinel lymph node biopsy before neoadjuvant systemic therapy in breast cancer. Breast Cancer Res Treat. 2017 May;163(1):93-101. doi: 10.1007/s10549-017-4163-2. Epub 2017 Feb 17.
PubMed 28213781
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Biopsy Before and/or After Neoadjuvant Chemotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT02031042
- Acronym / sponsor ID
- 2010/441-31/4
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant chemotherapy, breast cancer, sentinel lymph node biopsy, false negative rate, identification rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Collaborators
- Swedish Breast Cancer Group
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jan 2014 (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 purpose of this study is to investigate if sentinel lymph node biopsy is a reliable staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the sentinel lymph node is free of metastasis.
Detailed description
Sentinel lymph node biopsy (SLNB) was introduced in the late 1990´s and has become standard procedure for staging of the axilla in early stage breast cancer associated with significantly less arm morbidity than axillary lymph node dissection (ALND).
Neoadjuvant chemotherapy (NAC) given before breast surgery is indicated for locally advanced breast cancer but is increasingly used for early stage breast cancer with the purpose of downstaging the tumor and thereby possibly enabling breast conserving surgery. Traditionally, the standard axillary staging tool has been ALND although up to 50 per cent of the patients at diagnosis do not have any metastases in their axillary lymph nodes. In addition, NAC can eradicate metastases in the axillary lymph nodes in up to 40 per cent of the patients.
SLNB has therefore been evaluated in the neoadjuvant setting both before and after NAC but is still controversial and the timing debated.
This is a Swedish prospective multi-institutional study without any comparison goup. The comparison is between the findings in the SLNB and the following ALND performed after NAC in all patients.
If the patient is clinically node-negative at diagnosis a SLNB is performed before (without frozen section) and after NAC (substudy I). The reasons for repeating SLNB both before and after NAC are 1) to find out what happens during NAC 2) if it is possible to identify a repeat SLNB and 3) if it is reliable.
If the patient is node-positive at diagnosis (cytologically verified lymph node metastasis) SLNB is performed after NAC together with the breast operation and ALND (substudy II). When SLNB is performed after NAC, the sentinel lymph nodes are also analysed with frozen section in order to validate the method after chemotherapy. Both blue dye and radiolabelled isotope for localisation of the sentinel lymph node is recommended but lymphoscintigraphy is optional.
All consecutive clinically node-negative (or with unclear nodal status after ultrasound and cytology) patients planned for NAC will have oral and written information about the study by the responsible surgeon. After accepting to participate, the patient is asked to sign a written consent. Patients with a cytologically verified lymph node metastasis/es at diagnosis will be informed and asked to participate in substudy II after completion of NAC.
According to the statistical analysis, and with an expected loss of 10 per cent, a sample size of 220 patients is needed in substudy I to show that the false negative rate is less than 10 per cent. If we include 200 patients and 50 per cent are lymph node positive at diagnosis then the estimation of false negative rate will be based on 100 individuals. If we estimate the true false negative rate to be 8 per cent, then the precision with 80 per cent power will be +/- 7 per cent units (2-sided test with 95 per cent confidence interval).
The Central Contact (PI) is responsible for data collection, management and analysis. Each protocol will be sent together with a written consent and copies of all relevant histopathological reports to the PI, who will control for missing or incongruent data and if so, ask the responsible investigator on that institution/hospital to complement the missing data from the patients journal (copies of medical records or histopathological reports).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically verified breast cancer planned for neoadjuvant chemotherapy
Key inclusion criteria (2 listed)
- clinically node-negative (or unclear nodal status) substudy I
- signed consent from the study participant
Key exclusion criteria (4 listed)
- inflammatory breast cancer
- cytologically verified lymph node metastasis/es at diagnosis (substudy I), but these patients can be included in substudy II
- patients not able to give an informed consent
- hypersensitivity or allergy against blue dye or isotope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
False negative rate
Time frame: Up to two years
The rate of patients with no metastasis/ses in their sentinel lymph node/s before neoadjuvant chemotherapy (NAC) but metastasis/ses in the nodes from the axillary lymph node dissection performed after NAC will be analysed. In substudy II we also investigate the false negative rate in sentinel lymph node biopsies performed after NAC if the patient had positive lymph nodes at diagnosis.
1 secondary outcome
Identification rate
Time frame: Up to two years
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 28 Oct 2019.
- Background: PubMed 10400039Kuerer HM, Sahin AA, Hunt KK, Newman LA, Breslin TM, Ames FC, Ross MI, Buzdar AU, Hortobagyi GN, Singletary SE. Incidence and impact of documented eradication of breast cancer axillary lymph node metastases before surgery in patients treated with neoadjuvant chemotherapy. Ann Surg. 1999 Jul;230(1):72-8. doi: 10.1097/00000658-199907000-00011.
- Background: PubMed 14559892Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
- Background: PubMed 15837984Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
- Background: PubMed 16329089Xing Y, Foy M, Cox DD, Kuerer HM, Hunt KK, Cormier JN. Meta-analysis of sentinel lymph node biopsy after preoperative chemotherapy in patients with breast cancer. Br J Surg. 2006 May;93(5):539-46. doi: 10.1002/bjs.5209.
- Background: PubMed 12846861Schrenk P, Hochreiner G, Fridrik M, Wayand W. Sentinel node biopsy performed before preoperative chemotherapy for axillary lymph node staging in breast cancer. Breast J. 2003 Jul-Aug;9(4):282-7. doi: 10.1046/j.1524-4741.2003.09406.x.
- Background: PubMed 18683193Papa MZ, Zippel D, Kaufman B, Shimon-Paluch S, Yosepovich A, Oberman B, Sadetzki S. Timing of sentinel lymph node biopsy in patients receiving neoadjuvant chemotherapy for breast cancer. J Surg Oncol. 2008 Nov 1;98(6):403-6. doi: 10.1002/jso.21128.
- Background: PubMed 23683750Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
- Background: PubMed 24101169Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.
- Derived from this study: PubMed 28213781Zetterlund L, Celebioglu F, Axelsson R, de Boniface J, Frisell J. Swedish prospective multicenter trial on the accuracy and clinical relevance of sentinel lymph node biopsy before neoadjuvant systemic therapy in breast cancer. Breast Cancer Res Treat. 2017 May;163(1):93-101. doi: 10.1007/s10549-017-4163-2. Epub 2017 Feb 17.
- Homepage for the Swedish Breast Surgical AssociationLink provided by the sponsor.
- 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.
Linda H Zetterlund, PhD principal investigator
Dep. of Medical Research and Education, Karolinska Institutet (KI), Stockholm, Sweden
Fuat Celebioglu, PhD study chair
Dep. of Medical Research and Education, KI, Stockholm, Sweden
Jan Frisell, Professor study chair
Dep. of Molecular Medicine and Surgery, KI, Stockholm, Sweden
20 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, run by Stockholm South General Hospital at 20 sites in Sweden.
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 2 inclusion and 4 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 28 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 20 sites in Sweden. 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 (time frame: Up to two years). 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 NCT02031042, which also lists 9 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 28 Oct 2019.