Breast CancerPhase 3AMAROSNCT00014612
Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
A Phase 3 study testing axillary lymph node dissection, lymphoscintigraphy and therapeutic conventional surgery in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 29 sites in 8 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- axillary lymph node dissection, lymphoscintigraphy and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,813 participants
- Where
- 29 sitesin 8 countries
- Study dates
- Feb 2001to Mar 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer
- T0-2, N0
- Diagnosis by excisional tumorectomy allowed
- Clinically occult invasive disease must be histologically confirmed
- Only 1 tumor in 1 breast
- Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI
- Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
- Multicentric (i.e., in different quadrants) breast cancer is not allowed
- Clinically negative axillary lymph nodes
- No metastatic disease
- No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Any age
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to axilla
Surgery:
- No prior surgery to axilla
Other:
- See Disease Characteristics
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
Netherlands19 sites
Ziekenhuis Amstelland
Amstelveen, 1180AH
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, 7334 DZ
Rijnstate Hospital
Arnhem, 6800 TA
Reinier de Graaf Group - Delft
Delft, NL 2600 GA
NIJ Smellinghe
Drachten, NL-9200 DA
Catharina Ziekenhuis
Eindhoven, 5602 ZA
University Medical Center Groningen
Groningen, 9713 EZ
Kennemer Gasthuis - Locatie EG
Haarlem, 2000
Ropcke-Zweers Ziekenhuis
Hardenberg, 7770
Ziekenhuis St. Jansdal
Harderwijk, 3840 AC
Leiden University Medical Center
Leiden, 2300 CA
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, NL-6500 HB
Saint Laurentius Ziekenhuis
Roermond, 6043 CV
HagaZiekenhuis - Locatie Leyenburg
The Hague, 2545 CH
HagaZiekenhuis - Locatie Rode Kruis
The Hague, 2566 MJ
Ziekenhuis Bronovo
The Hague, 2597AX
University Medical Center Utrecht
Utrecht, 3584 CX
France2 sites
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043
Centre Oscar Lambret
Lille, 59020
Italy2 sites
Universita Degli Studi di Florence - Policlinico di Careggi
Firenze (Florence), 1 (50134)
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, 10123
United Kingdom2 sites
University Hospital of Wales
Cardiff, Wales, CF14 4XN
Wythenshawe Hospital
Manchester, England, M23 9LJ
Switzerland1 site
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
About this study
Official title: After Mapping Of The Axilla: Radiotherapy Or Surgery
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
- Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
- Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
- Compare the morbidity of patients treated with these regimens.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.
- Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
- Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.
Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.
Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.
- Conditions
- Breast Cancer
- Being tested
- axillary lymph node dissection, lymphoscintigraphy, therapeutic conventional surgery, radiation therapy
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary lymph node dissectionProcedure or surgery
lymphoscintigraphyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| axillary lymph node dissection | Active comparator | complete axillary lymph node dissection Receives: Procedure: axillary lymph node dissection; Procedure: lymphoscintigraphy; Procedure: therapeutic conventional surgery |
| axillary radiotherapy | Experimental | axillary radiotherapy, daily for 5 days a week, for 5 weeks Receives: Procedure: lymphoscintigraphy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary recurrence rate
Measured: from randomization
Secondary outcomes (5)
Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery
Measured: from randomization
Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery
Measured: from randomization
Axillary recurrence-free survival
Measured: from randomization
Disease-free survival
Measured: from randomization
Overall survival
Measured: from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2001
- Primary completionNov 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,813 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- ALMANAC Trialists Group, Borstkanker Onderzoeksgroup Nederland
- Responsible party
- Sponsor
- Investigators
- Emiel JT Rutgers, Study chair, The Netherlands Cancer InstituteRobert Mansel, Study chair, Cardiff and Vale University Health Board - University Hospital of Wales, CardiffCornelis Van De Velde, Study chair, Leiden University Medical Centre, LeidenGeertjan Van Tienhoven, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014612
- Sponsor's protocol ID
- EORTC-10981-22023
- Acronym
- AMAROS
- Status last verified
- Oct 2013
- First submitted
- 10 Apr 2001
- Last updated
- 29 Oct 2013
- Results posted
- No
Publications
Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Demonty G, Duez N, Cataliotti L, Klinkenbijl J, Westenberg HA, van der Mijle H, Hurkmans C, Rutgers EJ. Role of axillary clearance after a tumor-positive sentinel node in the administration of adjuvant therapy in early breast cancer. J Clin Oncol. 2010 Feb 10;28(5):731-7. doi: 10.1200/JCO.2008.21.7554. Epub 2009 Dec 28.
PubMed 20038733Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Duez N, Cataliotti L, Klinkenbijl JH, Westenberg HA, van der Mijle H, Snoj M, Hurkmans C, Rutgers EJ. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010 Jul;17(7):1854-61. doi: 10.1245/s10434-010-0945-z. Epub 2010 Mar 19.
PubMed 20300966Straver ME, Meijnen P, van Tienhoven G, et al.: Technical aspects of the sentinel node biopsy in the EORTC AMAROS sentinel node trial. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1006, 2008.
Meijnen P, Rutgers EJT, van de Velde CJH, et al.: EORTC 10981-22023 trial. AMAROS: after mapping of the axilla: radiotherapy or surgery? Trial update. [Abstract] Eur J Cancer 2 (Suppl 3): A-79, 79, 2004.
Hurkmans CW, Borger JH, Rutgers EJ, van Tienhoven G; EORTC Breast Cancer Cooperative Group; Radiotherapy Cooperative Group. Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run. Radiother Oncol. 2003 Sep;68(3):233-40. doi: 10.1016/s0167-8140(03)00194-4.
PubMed 13129630Donker M, Slaets L, van Tienhoven G, Rutgers EJ. [Axillary lymph node dissection versus axillary radiotherapy in patients with a positive sentinel node: the AMAROS trial]. Ned Tijdschr Geneeskd. 2015;159:A9302. Dutch.
PubMed 26488192Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.
PubMed 25439688Donker M, Straver ME, van Tienhoven G, van de Velde CJ, Mansel RE, Litiere S, Werutsky G, Duez NJ, Orzalesi L, Bouma WH, van der Mijle H, Nieuwenhuijzen GA, Veltkamp SC, Helen Westenberg A, Rutgers EJ. Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: identification rate and nodal outcome. Eur J Cancer. 2013 Jun;49(9):2093-100. doi: 10.1016/j.ejca.2013.02.017. Epub 2013 Mar 19.
PubMed 23522754
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Mapping Of The Axilla: Radiotherapy Or Surgery
- ClinicalTrials.gov ID
- NCT00014612
- Acronym / sponsor ID
- AMAROS / EORTC-10981-22023
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,813 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- ALMANAC Trialists Group, Borstkanker Onderzoeksgroup Nederland
- Study start
- Feb 2001
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
Detailed description
OBJECTIVES:
- Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
- Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
- Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
- Compare the morbidity of patients treated with these regimens.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.
- Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
- Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.
Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.
Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| axillary lymph node dissection | Active comparator | Procedure: axillary lymph node dissection, Procedure: lymphoscintigraphy, Procedure: therapeutic conventional surgerycomplete axillary lymph node dissection |
| axillary radiotherapy | Experimental | Procedure: lymphoscintigraphy, Procedure: therapeutic conventional surgery, Radiation: radiation therapyaxillary radiotherapy, daily for 5 days a week, for 5 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 lymph node dissection | Procedure or surgery | axillary lymph node dissection |
| lymphoscintigraphy | Procedure or surgery | axillary lymph node dissection, axillary radiotherapy |
| therapeutic conventional surgery | Procedure or surgery | axillary lymph node dissection, axillary radiotherapy |
| radiation therapy | Radiation | axillary radiotherapy |
Primary outcome
Axillary recurrence rate
Time frame: from randomization
5 secondary outcomes
Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery
Time frame: from randomization
Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery
Time frame: from randomization
Axillary recurrence-free survival
Time frame: from randomization
Disease-free survival
Time frame: from randomization
Overall survival
Time frame: from randomization
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 29 Oct 2013.
- Results publication: PubMed 20038733Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Demonty G, Duez N, Cataliotti L, Klinkenbijl J, Westenberg HA, van der Mijle H, Hurkmans C, Rutgers EJ. Role of axillary clearance after a tumor-positive sentinel node in the administration of adjuvant therapy in early breast cancer. J Clin Oncol. 2010 Feb 10;28(5):731-7. doi: 10.1200/JCO.2008.21.7554. Epub 2009 Dec 28.
- Results publication: PubMed 20300966Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Duez N, Cataliotti L, Klinkenbijl JH, Westenberg HA, van der Mijle H, Snoj M, Hurkmans C, Rutgers EJ. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010 Jul;17(7):1854-61. doi: 10.1245/s10434-010-0945-z. Epub 2010 Mar 19.
- Results publicationStraver ME, Meijnen P, van Tienhoven G, et al.: Technical aspects of the sentinel node biopsy in the EORTC AMAROS sentinel node trial. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1006, 2008.
- Results publicationMeijnen P, Rutgers EJT, van de Velde CJH, et al.: EORTC 10981-22023 trial. AMAROS: after mapping of the axilla: radiotherapy or surgery? Trial update. [Abstract] Eur J Cancer 2 (Suppl 3): A-79, 79, 2004.
- Results publication: PubMed 13129630Hurkmans CW, Borger JH, Rutgers EJ, van Tienhoven G; EORTC Breast Cancer Cooperative Group; Radiotherapy Cooperative Group. Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run. Radiother Oncol. 2003 Sep;68(3):233-40. doi: 10.1016/s0167-8140(03)00194-4.
- Derived from this study: PubMed 26488192Donker M, Slaets L, van Tienhoven G, Rutgers EJ. [Axillary lymph node dissection versus axillary radiotherapy in patients with a positive sentinel node: the AMAROS trial]. Ned Tijdschr Geneeskd. 2015;159:A9302. Dutch.
- Derived from this study: PubMed 25439688Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.
- Derived from this study: PubMed 23522754Donker M, Straver ME, van Tienhoven G, van de Velde CJ, Mansel RE, Litiere S, Werutsky G, Duez NJ, Orzalesi L, Bouma WH, van der Mijle H, Nieuwenhuijzen GA, Veltkamp SC, Helen Westenberg A, Rutgers EJ. Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: identification rate and nodal outcome. Eur J Cancer. 2013 Jun;49(9):2093-100. doi: 10.1016/j.ejca.2013.02.017. Epub 2013 Mar 19.
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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.
Emiel JT Rutgers study chair
The Netherlands Cancer Institute
Robert Mansel study chair
Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff
Cornelis Van De Velde study chair
Leiden University Medical Centre, Leiden
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing axillary lymph node dissection, lymphoscintigraphy and therapeutic conventional surgery in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 29 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Netherlands, France, Italy, United Kingdom, Poland and 3 more countries. 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?
Axillary recurrence rate (time frame: from randomization). 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 NCT00014612, which also lists 8 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 29 Oct 2013.