Axillary DissectionPhase 3SENTIBRASNCT01146158
Axillary Reverse Mapping for Breast Carcinomas
A Phase 3 study testing Axillary dissection for breast carcinomas in people with Axillary Dissection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Axillary Dissection
- What is being tested?
- Axillary dissection for breast carcinomas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Dec 2012
- Phase
- Phase 3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for formal Axillary Dissection (AD)
- N0 patient with a large tumor: T3
- N1 patient
- N2 patient with axillary imaging showing limited node involvement(1-4N+).
- Secondary AD after a positive sentinel node ( pN1, pN1(mi))
- AD after préopérative chemotherapy in a patient initially N+.
Show all 9Show fewer
- Age between 18 and 70
- Signature of the consent form.
- Patients beneficiary of the Social Security
Who cannot join
- N0 patient with an indication of Sentinel Node biopsy
- N2 patient with axillary imaging showing suspected node involvement >4N+.
- N3 patient
- Age over 70
- Pregnancy
- Blue dye allergy
- Mentally deficient patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.
Read the detailed description
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.
- Conditions
- Axillary Dissection
- Being tested
- Axillary dissection for breast carcinomas
- Keywords
- Axillary dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary dissection for breast carcinomasProcedure or surgery
Also called surgery Axillary dissection
surgery Axillary dissection
| Study group | Role | What they receive |
|---|---|---|
| surgery Axillary dissection | Experimental | surgery Axillary dissection Receives: Procedure: Axillary dissection for breast carcinomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the principal objectives is qualified as finding one or more radioactive node in zone D
Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein.
If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective
Measured: 1 day
Secondary outcomes (3)
Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node
Evaluate the incidence of metastatic or micro-metastatic disease within
Measured: 15 days
Evaluate the correlation between clinical and histological results
Evaluate the correlation between clinical and histological results
Measured: 15 days
Evaluate the morbidity associated with Axillary Dissection.
Evaluate the morbidity associated with Axillary Dissection.
Measured: 1 year, 2 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionDec 2012
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 Axillary DissectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude NOS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146158
- Sponsor's protocol ID
- P070154
- Acronym
- SENTIBRAS
- Status last verified
- May 2009
- First submitted
- 23 Apr 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nos C, Lesieur B, Clough KB, Lecuru F. Blue dye injection in the arm in order to conserve the lymphatic drainage of the arm in breast cancer patients requiring an axillary dissection. Ann Surg Oncol. 2007 Sep;14(9):2490-6. doi: 10.1245/s10434-007-9450-4. Epub 2007 Jun 5.
PubMed 17549570Nos C, Kaufmann G, Clough KB, Collignon MA, Zerbib E, Cusumano P, Lecuru F. Combined axillary reverse mapping (ARM) technique for breast cancer patients requiring axillary dissection. Ann Surg Oncol. 2008 Sep;15(9):2550-5. doi: 10.1245/s10434-008-0030-z. Epub 2008 Jul 11.
PubMed 18618185
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.
- ClinicalTrials.gov ID
- NCT01146158
- Acronym / sponsor ID
- SENTIBRAS / P070154
- Conditions
- Axillary Dissection
- Keywords
- Axillary dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jun 2010 (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.
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.
Detailed description
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery Axillary dissection | Experimental | Procedure: Axillary dissection for breast carcinomassurgery Axillary dissection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Indication for formal Axillary Dissection (AD)
- N0 patient with a large tumor: T3
- N1 patient
- N2 patient with axillary imaging showing limited node involvement(1-4N+).
- Secondary AD after a positive sentinel node ( pN1, pN1(mi))
Key exclusion criteria (7 listed)
- N0 patient with an indication of Sentinel Node biopsy
- N2 patient with axillary imaging showing suspected node involvement >4N+.
- N3 patient
- Age over 70
- 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 |
|---|---|---|
| Axillary dissection for breast carcinomasAlso: surgery Axillary dissectionsurgery Axillary dissection | Procedure or surgery | surgery Axillary dissection |
Primary outcome
Success of the principal objectives is qualified as finding one or more radioactive node in zone D
Time frame: 1 day
Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein. If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective
3 secondary outcomes
Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node
Time frame: 15 days
Evaluate the correlation between clinical and histological results
Time frame: 15 days
Evaluate the morbidity associated with Axillary Dissection.
Time frame: 1 year, 2 years and 5 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 8 Apr 2015.
- Background: PubMed 17549570Nos C, Lesieur B, Clough KB, Lecuru F. Blue dye injection in the arm in order to conserve the lymphatic drainage of the arm in breast cancer patients requiring an axillary dissection. Ann Surg Oncol. 2007 Sep;14(9):2490-6. doi: 10.1245/s10434-007-9450-4. Epub 2007 Jun 5.
- Background: PubMed 18618185Nos C, Kaufmann G, Clough KB, Collignon MA, Zerbib E, Cusumano P, Lecuru F. Combined axillary reverse mapping (ARM) technique for breast cancer patients requiring axillary dissection. Ann Surg Oncol. 2008 Sep;15(9):2550-5. doi: 10.1245/s10434-008-0030-z. Epub 2008 Jul 11.
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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.
Claude NOS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Axillary dissection for breast carcinomas in people with Axillary Dissection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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 8 Apr 2015. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success of the principal objectives is qualified as finding one or more radioactive node in zone D (time frame: 1 day). 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 NCT01146158, 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 8 Apr 2015.