Breast CancerPhase 2GAS2PLUSNCT00636467
Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm
A Phase 2 study testing No name in people with Breast Cancer, run by Centre Leon Berard at 22 sites in France.
Trial summary
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection). Eligible patients will only be registered (no randomization). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- No name
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 22 sitesFrance
- Study dates
- Mar 2008to Sep 2011
- Phase
- Phase 2
- 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, age ≥ 18 years
- Patient with invasive unifocal breast cancer with tumor size > 2 cm at initial examination (clinical examination and/or imaging)
- Preoperative histological diagnosis of infiltrating mammary carcinoma
- No lymph node at clinical examination
- No treatment for this cancer before surgery
- Mandatory affiliation with a social security system
- Written, signed informed consent
Who cannot join
- No invasive breast cancer
- Breast tumor =< 2 cm
- Preoperative histological diagnosis other than infiltrating mammary carcinoma
- Multifocal breast cancer
- Inflammatory breast cancer
- Metastatic cancer
Show all 12Show fewer
- History of homolateral breast surgery
- History of allergic disorders
- History of homolateral breast cancer
- Difficult follow-up
- Pregnant or lactating woman
- Previous inclusion in the trial
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Centre Paul Papin
Angers, 49033
Institut Bergonié
Bordeaux, 33076
CH Boulogne sur Mer
Boulogne-sur-Mer, 62321
CH Calais
Calais, 62107
Clinique des 2 Caps
Coquelles, 62231
Clinique des Acacias
Cucq, 62780
Clinique Pasteur
Guilherand-Granges, 07500
Centre Oscar Lambret
Lille, 59000
Hôtel Dieu
Lyon, 69002
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13009
Centre Val d'Aurelle
Montpellier, 34005
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CH Arrondissement Montreuil sur Mer
Rang-du-Fliers, 62180
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Centre René Huguenin
Saint-Cloud, 92210
CHRU Saint Etienne
Saint-Etienne, 42055
Centre René Gauducheau
Saint-Herblain, 44805
CMCO
Saint-Martin-Boulogne, 62280
Institut Claudius Régaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).
Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.
The number of patients required in this multicentric and prospective study is 240 (16 participating centers).
Read the detailed description
Axillary node extension is one of the major prognostic factors in breast cancer. Axillary dissection of Berg level I and II nodes is the validated method to obtain information on lymph node invasion, but it is associated with important morbidity.
Sentinel lymph node assessment (SLN) was developed to select patients likely not to have axillary node extension using a technique less invasive than conventional dissection. Axillary dissection is restricted to patients with undetected or metastatic SLN.
SLN detection involves subareolar or peri-tumoral injection of lymphotropic contrast agents which map the regional lymphatic drainage pattern of the tumor.
This technique allows an optimization of histopathological analysis: the pathologist must analyze only two nodes on average (instead of 10-15), allowing the examination of numerous tissue sections and the development of specific techniques such as immunohistochemistry.
The principal indicators of success for the technique are the detection rate, the false negative rate and the number of SLN sampled.
The assessment of feasibility is based on concomitant histopathological analysis of the SLN and of complementary lymph nodes.
There is no consensus in the literature on the SLN technique to be used for tumors with clinical size superior to 2 cm in diameter.
The aim of this prospective, multicentric study is to evaluate the performance of the SLN technique, in terms of detection rate and false negative rate, for patients with tumors greater than 2 cm (clinical measurement).
A homogeneous technique with "combined", colorimetric and isotopic SLN detection with subareolar or peri-tumoral injection will be used. This consensus "combined" technique has been validated by all investigators. The histopathological procedure will also be homogeneous, and validated within the group of pathologists of the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC). Breast surgery will either be a mastectomy or conservative treatment.
The primary objective of the study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).
The secondary objectives are:
- Evaluation of the number of SLN sampled per patient,
- Lymphoscintigraphic evaluation of the pattern of lymphatic drainage in breast tumors > 2 centimeters,
- Precise histopathological description of the SLN sampled and of axillary nodes of levels I and II.
Evaluation criteria:
The primary criterion is the rate of false negatives, determined by the ratio of the number of patients with detected but negative SLN to the total number of positive non-sentinel nodes at the time of axillary dissection of levels I and II (patients classified as N+ according to the TNM system).
This rate will be determined after calculation of the detection rate, determined by the ratio of the number of patients evaluated on the total number of patients.
In agreement with international recommendations, the expected rate of false negatives should be < 5 % with a detection rate > 85 %.
Secondary criteria include:
- Total number of sampled SLN per patient,
- Lymphoscintigraphy: detection of SLN by means of extra-axillary markings,
- Histopathological results:
- SLN: metastases, capsular breach, micro metastases, isolated cells,
- Dissection: number of positive nodes.
- Conditions
- Breast Cancer
- Being tested
- No name
- Keywords
- Breast cancer (tumors> 2 cm), Detection, Axillary sentinel lymph node
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No nameOther
Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
| Study group | Role | What they receive |
|---|---|---|
| No label | Experimental | Injection of Nanocis® or Nanocoll® (Tc-colloid) on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2) Receives: Other: No name |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality criteria of the SLN detection technique
Measured: 1 month
Secondary outcomes (4)
Total number of sampled SLN per patient
Measured: 1 month
Detection of SLN by means of extra-axillary markings (lymphoscintigraphy)
Measured: 1 month
Histopathological results (SLN)
Measured: 1 month
Histopathological results (dissection)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- PHRC 2007: financial support
- Responsible party
- Sponsor
- Investigators
- Hervé MIGNOTTE, MD, Principal investigator, Centre Leon Berard, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636467
- Sponsor's protocol ID
- GAS2PLUS
- Other IDs
- ET2007-045
- Acronym
- GAS2PLUS
- Status last verified
- Sep 2012
- First submitted
- 8 Feb 2008
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. doi: 10.1056/NEJM199504063321401.
PubMed 7877646Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.
PubMed 1637663Ververs JM, Roumen RM, Vingerhoets AJ, Vreugdenhil G, Coebergh JW, Crommelin MA, Luiten EJ, Repelaer van Driel OJ, Schijven M, Wissing JC, Voogd AC. Risk, severity and predictors of physical and psychological morbidity after axillary lymph node dissection for breast cancer. Eur J Cancer. 2001 May;37(8):991-9. doi: 10.1016/s0959-8049(01)00067-3.
PubMed 11334724Kissin MW, Querci della Rovere G, Easton D, Westbury G. Risk of lymphoedema following the treatment of breast cancer. Br J Surg. 1986 Jul;73(7):580-4. doi: 10.1002/bjs.1800730723.
PubMed 3730795Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015.
PubMed 8092905Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6.
PubMed 8130940Glass EC, Essner R, Giuliano AE. Sentinel node localization in breast cancer. Semin Nucl Med. 1999 Jan;29(1):57-68. doi: 10.1016/s0001-2998(99)80030-0.
PubMed 9990684Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg. 1997 Sep;226(3):271-6; discussion 276-8. doi: 10.1097/00000658-199709000-00006.
PubMed 9339933McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6. doi: 10.1200/JCO.2000.18.13.2560.
PubMed 10893287Weaver DL, Krag DN, Ashikaga T, Harlow SP, O'Connell M. Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer. 2000 Mar 1;88(5):1099-107.
PubMed 10699901Tafra L, McMasters KM, Whitworth P, Edwards MJ. Credentialing issues with sentinel lymph node staging for breast cancer. Am J Surg. 2000 Oct;180(4):268-73. doi: 10.1016/s0002-9610(00)00466-9.
PubMed 11113433McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, Carlson DJ, Laidley AL, McGlothin TQ, Ley PB, Brown CM, Glaser RL, Pennington RE, Turk PS, Simpson D, Edwards MJ; University of Louisville Breast Cancer Study Group. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: a model for implementation of new surgical techniques. Ann Surg. 2001 Sep;234(3):292-9; discussion 299-300. doi: 10.1097/00000658-200109000-00003.
PubMed 11524582Orr RK, Hoehn JL, Col NF. The learning curve for sentinel node biopsy in breast cancer: practical considerations. Arch Surg. 1999 Jul;134(7):764-7. doi: 10.1001/archsurg.134.7.764.
PubMed 10401830Bedrosian I, Reynolds C, Mick R, Callans LS, Grant CS, Donohue JH, Farley DR, Heller R, Conant E, Orel SG, Lawton T, Fraker DL, Czerniecki BJ. Accuracy of sentinel lymph node biopsy in patients with large primary breast tumors. Cancer. 2000 Jun 1;88(11):2540-5. doi: 10.1002/1097-0142(20000601)88:113.0.co;2-a.
PubMed 10861431Chung MH, Ye W, Giuliano AE. Role for sentinel lymph node dissection in the management of large (> or = 5 cm) invasive breast cancer. Ann Surg Oncol. 2001 Oct;8(9):688-92. doi: 10.1007/s10434-001-0688-y.
PubMed 11597008
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
- ClinicalTrials.gov ID
- NCT00636467
- Acronym / sponsor ID
- GAS2PLUS / GAS2PLUS
- Conditions
- Breast Cancer
- Keywords
- Breast cancer (tumors> 2 cm), Detection, Axillary sentinel lymph node
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- PHRC 2007: financial support
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Mar 2008 (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 evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).
Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.
The number of patients required in this multicentric and prospective study is 240 (16 participating centers).
Detailed description
Axillary node extension is one of the major prognostic factors in breast cancer. Axillary dissection of Berg level I and II nodes is the validated method to obtain information on lymph node invasion, but it is associated with important morbidity.
Sentinel lymph node assessment (SLN) was developed to select patients likely not to have axillary node extension using a technique less invasive than conventional dissection. Axillary dissection is restricted to patients with undetected or metastatic SLN.
SLN detection involves subareolar or peri-tumoral injection of lymphotropic contrast agents which map the regional lymphatic drainage pattern of the tumor.
This technique allows an optimization of histopathological analysis: the pathologist must analyze only two nodes on average (instead of 10-15), allowing the examination of numerous tissue sections and the development of specific techniques such as immunohistochemistry.
The principal indicators of success for the technique are the detection rate, the false negative rate and the number of SLN sampled.
The assessment of feasibility is based on concomitant histopathological analysis of the SLN and of complementary lymph nodes.
There is no consensus in the literature on the SLN technique to be used for tumors with clinical size superior to 2 cm in diameter.
The aim of this prospective, multicentric study is to evaluate the performance of the SLN technique, in terms of detection rate and false negative rate, for patients with tumors greater than 2 cm (clinical measurement).
A homogeneous technique with "combined", colorimetric and isotopic SLN detection with subareolar or peri-tumoral injection will be used. This consensus "combined" technique has been validated by all investigators. The histopathological procedure will also be homogeneous, and validated within the group of pathologists of the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC). Breast surgery will either be a mastectomy or conservative treatment.
The primary objective of the study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).
The secondary objectives are:
- Evaluation of the number of SLN sampled per patient,
- Lymphoscintigraphic evaluation of the pattern of lymphatic drainage in breast tumors > 2 centimeters,
- Precise histopathological description of the SLN sampled and of axillary nodes of levels I and II.
Evaluation criteria:
The primary criterion is the rate of false negatives, determined by the ratio of the number of patients with detected but negative SLN to the total number of positive non-sentinel nodes at the time of axillary dissection of levels I and II (patients classified as N+ according to the TNM system).
This rate will be determined after calculation of the detection rate, determined by the ratio of the number of patients evaluated on the total number of patients.
In agreement with international recommendations, the expected rate of false negatives should be < 5 % with a detection rate > 85 %.
Secondary criteria include:
- Total number of sampled SLN per patient,
- Lymphoscintigraphy: detection of SLN by means of extra-axillary markings,
- Histopathological results:
- SLN: metastases, capsular breach, micro metastases, isolated cells,
- Dissection: number of positive nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No label | Experimental | Other: No nameInjection of Nanocis® or Nanocoll® (Tc-colloid) on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, age ≥ 18 years
- Patient with invasive unifocal breast cancer with tumor size > 2 cm at initial examination (clinical examination and/or imaging)
- Preoperative histological diagnosis of infiltrating mammary carcinoma
- No lymph node at clinical examination
- No treatment for this cancer before surgery
Key exclusion criteria (12 listed)
- No invasive breast cancer
- Breast tumor =< 2 cm
- Preoperative histological diagnosis other than infiltrating mammary carcinoma
- Multifocal breast cancer
- Inflammatory breast cancer
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 |
|---|---|---|
| No nameInjection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2) | Other | No label |
Primary outcome
Quality criteria of the SLN detection technique
Time frame: 1 month
4 secondary outcomes
Total number of sampled SLN per patient
Time frame: 1 month
Detection of SLN by means of extra-axillary markings (lymphoscintigraphy)
Time frame: 1 month
Histopathological results (SLN)
Time frame: 1 month
Histopathological results (dissection)
Time frame: 1 month
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 26 Sep 2012.
- Background: PubMed 7877646Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. doi: 10.1056/NEJM199504063321401.
- Background: PubMed 1637663Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.
- Background: PubMed 11334724Ververs JM, Roumen RM, Vingerhoets AJ, Vreugdenhil G, Coebergh JW, Crommelin MA, Luiten EJ, Repelaer van Driel OJ, Schijven M, Wissing JC, Voogd AC. Risk, severity and predictors of physical and psychological morbidity after axillary lymph node dissection for breast cancer. Eur J Cancer. 2001 May;37(8):991-9. doi: 10.1016/s0959-8049(01)00067-3.
- Background: PubMed 3730795Kissin MW, Querci della Rovere G, Easton D, Westbury G. Risk of lymphoedema following the treatment of breast cancer. Br J Surg. 1986 Jul;73(7):580-4. doi: 10.1002/bjs.1800730723.
- Background: PubMed 8092905Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015.
- Background: PubMed 8130940Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6.
- Background: PubMed 9990684Glass EC, Essner R, Giuliano AE. Sentinel node localization in breast cancer. Semin Nucl Med. 1999 Jan;29(1):57-68. doi: 10.1016/s0001-2998(99)80030-0.
- Background: PubMed 9339933Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg. 1997 Sep;226(3):271-6; discussion 276-8. doi: 10.1097/00000658-199709000-00006.
- Background: PubMed 10893287McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6. doi: 10.1200/JCO.2000.18.13.2560.
- Background: PubMed 10699901Weaver DL, Krag DN, Ashikaga T, Harlow SP, O'Connell M. Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer. 2000 Mar 1;88(5):1099-107.
- Background: PubMed 11113433Tafra L, McMasters KM, Whitworth P, Edwards MJ. Credentialing issues with sentinel lymph node staging for breast cancer. Am J Surg. 2000 Oct;180(4):268-73. doi: 10.1016/s0002-9610(00)00466-9.
- Background: PubMed 11524582McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, Carlson DJ, Laidley AL, McGlothin TQ, Ley PB, Brown CM, Glaser RL, Pennington RE, Turk PS, Simpson D, Edwards MJ; University of Louisville Breast Cancer Study Group. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: a model for implementation of new surgical techniques. Ann Surg. 2001 Sep;234(3):292-9; discussion 299-300. doi: 10.1097/00000658-200109000-00003.
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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.
Hervé MIGNOTTE, MD principal investigator
Centre Leon Berard, Lyon
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing No name in people with Breast Cancer, run by Centre Leon Berard at 22 sites 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 7 inclusion and 12 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 26 Sep 2012. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Quality criteria of the SLN detection technique (time frame: 1 month). 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 NCT00636467, which also lists 19 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 26 Sep 2012.