Breast Cancer Clinical Trial
— AMAROSOfficial 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.
Status | Completed |
Enrollment | 4813 |
Est. completion date | March 2013 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU de Grenoble - Hopital de la Tronche | Grenoble | |
France | Centre Oscar Lambret | Lille | |
Italy | Universita Degli Studi di Florence - Policlinico di Careggi | Firenze (Florence) | |
Italy | Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Turin | |
Netherlands | HagaZiekenhuis - Locatie Leyenburg | 's-Gravenhage | |
Netherlands | Ziekenhuis Amstelland | Amstelveen | |
Netherlands | Academisch Medisch Centrum at University of Amsterdam | Amsterdam | |
Netherlands | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | |
Netherlands | Gelre Ziekenhuizen - Lokatie Lukas | Apeldoorn | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Reinier de Graaf Group - Delft | Delft | |
Netherlands | HagaZiekenhuis - Locatie Rode Kruis | Den Haag | |
Netherlands | Ziekenhuis Bronovo | Den Haag | |
Netherlands | NIJ Smellinghe | Drachten | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Kennemer Gasthuis - Locatie EG | Haarlem | |
Netherlands | Ropcke-Zweers Ziekenhuis | Hardenberg | |
Netherlands | Ziekenhuis St. Jansdal | Harderwijk | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | |
Netherlands | Saint Laurentius Ziekenhuis | Roermond | |
Netherlands | University Medical Center Utrecht | Utrecht | |
Poland | Medical University of Gdansk | Gdansk | |
Slovenia | Institute of Oncology - Ljubljana | Ljubljana | |
Switzerland | Hopital Cantonal Universitaire de Geneve | Geneva | |
Turkey | Marmara University Hospital | Istanbul | |
United Kingdom | University Hospital of Wales | Cardiff | Wales |
United Kingdom | Wythenshawe Hospital | Manchester | England |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | ALMANAC Trialists Group, Borstkanker Onderzoeksgroup Nederland |
France, Italy, Netherlands, Poland, Slovenia, Switzerland, Turkey, United Kingdom,
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):23 — View Citation
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.
Straver 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.
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 — View Citation
Straver 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 1098 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Axillary recurrence rate | from randomization | No | |
Secondary | Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery | from randomization | No | |
Secondary | 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 | from randomization | No | |
Secondary | Axillary recurrence-free survival | from randomization | No | |
Secondary | Disease-free survival | from randomization | No | |
Secondary | Overall survival | from randomization | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |