Breast NeoplasmsNCT02112682
Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
A study testing Completion axillary treatment in people with Breast Neoplasms, run by Maastricht University Medical Center at 31 sites in Netherlands.
Trial summary
STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. 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?
- Completion axillary treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 31 sitesNetherlands
- Study dates
- Jun 2014to Mar 2018
- 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
- Female
- Aged 18 years or older
- Pathologically confirmed invasive unilateral breast carcinoma
- A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
- Will be or is treated with mastectomy
- Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
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- Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
- pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
- Written informed consent
Who cannot join
- Clinically node positive pre-operative
- Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- Solitary parasternal sentinel lymph node metastasis (pN1b)
- Bilateral breast cancer
- Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
- Evidence of metastatic disease
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- History of invasive breast cancer
- Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
- Pregnant or nursing
- Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
- Unable or unwilling to give informed consent
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Netherlands31 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch
Flevoziekenhuis
Almere Stad
Meander Medisch Centrum
Amersfoort
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam
Gelre Ziekenhuizen
Apeldoorn
Rijnstate
Arnhem
Amphia ziekenhuis
Breda
Reinier de Graaf
Delft
Deventer Ziekenhuis
Deventer
Catharina Ziekenhuis Eindhoven
Eindhoven
Medisch Spectrum Twente
Enschede
Groene Hart Ziekenhuis
Gouda
Martini Ziekenhuis
Groningen
UMC Groningen
Groningen
Zuyderland Medisch Centrum
Heerlen
Tergooi
Hilversum
Alrijne ziekenhuis
Leiden
Maastricht University Medical Centre+
Maastricht, Limburg, 6202 AZ
St. Antonius Ziekenhuis
Nieuwegein
Canisius-Wilhelmina Ziekenhuis
Nijmegen
Radboud university medical center
Nijmegen
Laurentius Ziekenhuis
Roermond
Zuyderland Medisch Centrum
Sittard
Antonius Ziekenhuis
Sneek
Bronovo / Medisch Centrum Haaglanden
The Hague
Haga Ziekenhuis
The Hague
Rivierenland
Tiel
St. Elisabeth Ziekenhuis
Tilburg
Diakonessenhuis Utrecht
Utrecht
Maxima Medisch Centrum
Veldhoven
Isala Klinieken
Zwolle
About this study
Official title: The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.
PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.
HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.
- Conditions
- Breast Neoplasms
- Being tested
- Completion axillary treatment
- Keywords
- Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion axillary treatmentProcedure or surgery
Completion axillary treatment according to the Dutch breast cancer guideline
| Study group | Role | What they receive |
|---|---|---|
| Completion axillary treatment | Active comparator | Completion axillary treatment according to the Dutch breast cancer guideline Receives: Procedure: Completion axillary treatment |
| No completion axillary treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence rate
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Measured: up to ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: slow accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Marjolein L Smidt, MD, PhD, Principal investigator, Maastricht University Medical Centre+, Maastricht, the NetherlandsHans JW de Wilt, MD, PhD, Principal investigator, Radboud University Medical Centre, Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112682
- Sponsor's protocol ID
- BOOG 2013-07
- Other IDs
- KWF UM 2013-5920
- Status last verified
- May 2018
- First submitted
- 10 Apr 2014
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Roozendaal LM, de Wilt JH, van Dalen T, van der Hage JA, Strobbe LJ, Boersma LJ, Linn SC, Lobbes MB, Poortmans PM, Tjan-Heijnen VC, Van de Vijver KK, de Vries J, Westenberg AH, Kessels AG, Smidt ML. The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC Cancer. 2015 Sep 3;15:610. doi: 10.1186/s12885-015-1613-2.
PubMed 26335105
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
- ClinicalTrials.gov ID
- NCT02112682
- Acronym / sponsor ID
- BOOG 2013-07
- Conditions
- Breast Neoplasms
- Keywords
- Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual rate
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University
- Study start
- Jun 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Apr 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.
STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.
PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.
HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Completion axillary treatment | Active comparator | Procedure: Completion axillary treatmentCompletion axillary treatment according to the Dutch breast cancer guideline |
| No completion axillary treatment | No intervention | – |
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)
- Female
- Aged 18 years or older
- Pathologically confirmed invasive unilateral breast carcinoma
- A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
- Will be or is treated with mastectomy
Key exclusion criteria (11 listed)
- Clinically node positive pre-operative
- Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- Solitary parasternal sentinel lymph node metastasis (pN1b)
- Bilateral breast cancer
- Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
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 |
|---|---|---|
| Completion axillary treatmentCompletion axillary treatment according to the Dutch breast cancer guideline | Procedure or surgery | Completion axillary treatment |
Primary outcome
Regional recurrence rate
Time frame: up to ten years
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Results and safety
The study was stopped early (reason given: slow accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 26335105van Roozendaal LM, de Wilt JH, van Dalen T, van der Hage JA, Strobbe LJ, Boersma LJ, Linn SC, Lobbes MB, Poortmans PM, Tjan-Heijnen VC, Van de Vijver KK, de Vries J, Westenberg AH, Kessels AG, Smidt ML. The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC Cancer. 2015 Sep 3;15:610. doi: 10.1186/s12885-015-1613-2.
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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.
Marjolein L Smidt, MD, PhD principal investigator
Maastricht University Medical Centre+, Maastricht, the Netherlands
Hans JW de Wilt, MD, PhD principal investigator
Radboud University Medical Centre, Nijmegen, the Netherlands
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Completion axillary treatment in people with Breast Neoplasms, run by Maastricht University Medical Center at 31 sites in Netherlands.
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 11 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: stopped early, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Netherlands. 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 was stopped early (reason given: slow accrual rate). Results are not available in the source record.
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?
Regional recurrence rate (time frame: up to ten 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 NCT02112682, which also lists 1 linked publication.
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 9 May 2018.