Breast CancerSENOMICNCT02049632
Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
A study testing Omission of axillary clearance in people with Breast Cancer, run by Karolinska Institutet at 22 sites in Sweden.
Trial summary
Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omission of axillary clearance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 805 participants
- Where
- 22 sitesSweden
- Study dates
- Dec 2013to 31 Dec 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)
- Histopathology results demonstrate SN micrometastases.
- Patients who undergo mastectomy (protocol change from April 2017 onwards)
- The patient must have given verbal and written consent.
Who cannot join
- Preoperatively diagnosed lymph node metastases.
- Sentinel node metastases > 2 mm.
- Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
- History of previous breast cancer.
- Pregnancy.
- Bilateral breast cancer where any of the other exclusion criteria applies to either side.
- Medical contraindication for systemic adjuvant therapy
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Sweden22 sites
Sahlgrenska University Hospital
Gothenburg
Helsingborgs Hospital
Helsingborg
Kalmar Hospital
Kalmar
Karlskrona Hospital
Karlskrona
Kristianstad Hospital
Kristianstad
Lidköping Hospital
Lidköping
Linköping University Hospital
Linköping
Lund and Malmö University Hospital
Lund
Örebro University Hospital
Örebro
Skövde Hospital
Skövde
Karolinska University Hospital
Stockholm, 17176
Capio St Görans Hospital
Stockholm
Danderyds Hospital AB
Stockholm
Southern General Hospital
Stockholm
Sundsvall Hospital
Sundsvall
Uddevalla Hospital
Uddevalla
Umeå University Hospital
Umeå
Akademiska Universitetssjukhuset
Uppsala
Varberg Hospital
Varberg
Västmanlands Hospital
Västerås
Västervik Hospital
Västervik
Växjö Hospital
Vaxjo
About this study
Official title: Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study
Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.
However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.
This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.
Read the detailed description
From April 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into SENOMIC. The inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in SENOMIC anymore. Recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.
- Conditions
- Breast Cancer
- Being tested
- Omission of axillary clearance
- Keywords
- Breast cancer, Sentinel Node Biopsy, Micrometastasis, Axillary lymph node dissection
- Medical subject headings
- Breast Neoplasms, Neoplasm Micrometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of axillary clearanceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Omission of axillary clearance | Experimental | No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases Receives: Procedure: Omission of axillary clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: Five years
Secondary outcomes (1)
Axillary recurrence rate
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startDec 2013
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Centrallasarettet Västerås, Uppsala University
- Responsible party
- Principal investigator, Jana de Boniface, Karolinska University Hospital
- Investigators
- Jana M de Boniface, MD, PhD, Principal investigator, Karolinska InstitutetJan Frisell, Professor, Principal investigator, Karolinska InstitutetLeif Bergkvist, Professor, Principal investigator, Uppsala UniversityYvette Andersson, MD, PhD, Principal investigator, Västmanlands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049632
- Sponsor's protocol ID
- SENOMIC
- Acronym
- SENOMIC
- Status last verified
- Mar 2023
- First submitted
- 24 Jan 2014
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study
- ClinicalTrials.gov ID
- NCT02049632
- Acronym / sponsor ID
- SENOMIC / SENOMIC
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Sentinel Node Biopsy, Micrometastasis, Axillary lymph node dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Centrallasarettet Västerås, Uppsala University
- Study start
- Dec 2013
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 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.
Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.
However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.
This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.
Detailed description
From April 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into SENOMIC. The inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in SENOMIC anymore. Recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omission of axillary clearance | Experimental | Procedure: Omission of axillary clearanceNo axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)
- Histopathology results demonstrate SN micrometastases.
- Patients who undergo mastectomy (protocol change from April 2017 onwards)
- The patient must have given verbal and written consent.
Key exclusion criteria (7 listed)
- Preoperatively diagnosed lymph node metastases.
- Sentinel node metastases > 2 mm.
- Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
- History of previous breast cancer.
- Pregnancy.
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 |
|---|---|---|
| Omission of axillary clearance | Procedure or surgery | Omission of axillary clearance |
Primary outcome
Disease-free survival
Time frame: Five years
1 secondary outcome
Axillary recurrence rate
Time frame: Five 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 10 Mar 2023.
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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.
Jana M de Boniface, MD, PhD principal investigator
Karolinska Institutet
Jan Frisell, Professor principal investigator
Karolinska Institutet
Leif Bergkvist, Professor principal investigator
Uppsala University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of axillary clearance in people with Breast Cancer, run by Karolinska Institutet at 22 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 4 inclusion and 7 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Disease-free survival (time frame: Five years). 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 10 Mar 2023.