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حالة التجربة السريرية NCT06529302 لـ سرطان الثدي هي نشط (التجنيد مغلق). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة

The OPBC-07/microNAC Study

نشط (التجنيد مغلق)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06529302 هي دراسة رصدية لـسرطان الثدي وهي نشط (التجنيد مغلق). بدأت في ٧ ذو القعدة ١٤٤٥ هـ مع خطة لتجنيد ٢٬٠٠٠ مشاركًا. يقودها University Hospital, Basel, Switzerland، ومن المتوقع اكتمالها بحلول ٥ ذو الحجة ١٤٤٦ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٤ رجب ١٤٤٦ هـ.
الملخص
The aim of this multicenter retrospective cohort study is to determine the safety of omission of axillary lymph node dissection in patients with residual micrometastases after neoadjuvant chemotherapy.
وصف مفصل
Chemotherapy before surgery, known as neoadjuvant chemotherapy (NAC), is often used to treat patients with advanced breast cancer or aggressive early-stage breast cancer. Research shows that about one in four early-stage breast cancer patients receives this treatment.

For patients undergoing NAC, standard of care includes checking the lymph nodes under the arm (axillary lymph nodes) using a procedure called Sentinel lymph node biopsy to determine if the cancer has spread. In cases where the cancer has spread to the lymph nodes but then shrinks or disappears after chemotherapy, special techniques like dual tracer mapping, targeted axillary dissection, or the Marking Axillary Lymph Nodes with Iodine Seeds procedure are used to ensure accurate biopsy results.

For patients whose cancer shrinks completely in the lymph nodes, it is generally safe to skip further surgery to remove more lymph nodes, a procedure called axillary lymph node dissection (ALND). However, if cancer remains in the lymph nodes, more lymph nodes are typically removed because there is a high chance that cancer is still present.

An increasing number of surgeons are starting to omit ALND, especially when only tiny amounts of cancer (micrometastases) remain. To ensure this practice is safe, real-world data on patient outcomes over time is needed.

This multicenter retrospective cohort study aims to assess the safety of omitting ALND in patients with residual micrometastases after NAC for breast cancer. The study analyzes data of breast cancer patients treated between 2013 and 2024 at more than 50 centers that are part of the Oncoplastic Breast Consortium.

The results of this study will provide valuable information to help doctors determine the best treatment approach for their patients.

العنوان الرسمي

Association of Axillary Lymph Node Dissection With Oncological Outcomes in Patients With Residual Micrometastases After Neoadjuvant Chemotherapy: The OPBC-07/microNAC Study

الحالات الطبية
سرطان الثدي
معرّفات دراسة أخرى
  • 2024-00186; bb24Weber
NCT معرّف
تاريخ البدء (فعلي)
2024-05-15
آخر تحديث مُنشور
2025-01-24
تاريخ الاكتمال (المقدر)
2025-06
عدد المشاركين المخطط لهم
٢٬٠٠٠
نوع الدراسة
رصدية
الحالة
نشط (التجنيد مغلق)
الكلمات الرئيسية
Neoadjuvant chemotherapy
Axillary lymph node dissection
Residual micrometastases
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
5-year rate of any axillary recurrence
Assessment of the incidence of any axillary recurrence, which is defined as isolated or combined with local or distant recurrence.
5 years
5-year rate of isolated axillary recurrence
Assessment of the incidence of isolated axillary recurrence.
5 years
Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection
The incidence of axillary recurrence is compared between patients that were treated with and without axillary dissection.
5 years
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Proportion of patients with additional micro- and macrometastases removed by axillary lymph node dissection
Assessment of the proportion of patients with additional micro- and macrometastases that were removed by axillary lymph node dissection.
5 years
5-year rates of locoregional and any invasive recurrence
Assessment of the incidence of locoregional and any invasive recurrence.
5 years
Comparison of 5-year rate of locoregional and any invasive recurrence in patients treated with and without axillary lymph node dissection
The incidence of locoregional and any invasive recurrence is compared between patients that were treated with and without axillary lymph node dissection.
5 years
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • Consecutive women and men aged 18 years or older with a diagnosis of stage I-III breast cancer (any histological and receptor subtype)
  • For Clinically Node negative (cN0) at presentation: any axillary staging technique including palpation is allowed. Dual tracer mapping is not required for Sentinel Lymph Node Biopsy (SLNB)
  • For Clinically Node positive (cN+) at presentation: Biopsy proven confirmation is required. Staging techniques include: SLNB with dual mapping or targeted axillary dissection (Targeted Axillary Dissection, TAD: imaging-guided localization of sampled node in combination with Sentinel Lymph Node procedure with or without dual mapping) or the Marking Axillary Lymph Nodes with Iodine Seeds (MARI) procedure
  • Completed neoadjuvant chemotherapy
  • Residual micrometastases detected on SLNB or TAD or MARI (on frozen section or final pathology)
  • Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed
  • Received axillary treatment with completion axillary lymph node dissection (ALND), axillary Radiotherapy (ART), both or none
  • At least 1-year follow-up (inclusion should end in May 2023)
  • Had surgery at any time point until May 2023 at the latest
  • Prior history of stage I-III (not stage IV) breast cancer is allowed

  • Did not undergo SLNB/TAD/MARI (e.g., went straight to ALND or ART)
  • Presence of ITCs alone or macrometastases on the sentinel nodes (or TAD nodes or MARI node)
  • Stage IV disease at presentation
  • Inflammatory breast cancer at presentation
  • Neoadjuvant endocrine therapy
  • Micrometastases detected by One-step nucleic acid amplification (OSNA)
University Hospital, Basel, Switzerland logoUniversity Hospital, Basel, Switzerland
Memorial Sloan Kettering Cancer Center logoمركز ميموريال سلون كيترينج للسرطان
لا توجد بيانات اتصال.
84 مواقع الدراسة في 30 بلدان
Mansoura oncology center, Al Mansurah, Egypt

Arizona

Valleywise Health Medical Center, Phoenix, Arizona, 85008, United States

California

Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
University of California, San Francisco, California, 94158, United States
Providence Saint John's Cancer Institute, Santa Monica, California, 90404, United States

Florida

University of Miami, Coral Gables, Florida, 33146, United States

Massachusetts

Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Michigan

University of Michigan, Ann Arbor, Michigan, 48109, United States

Minnesota

Mayo Clinic, Rochester, Minnesota, 55905, United States

New York

NYU Langone Health, New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Montefiore Medical Center, New York, New York, 10467, United States
University of Rochester, Rochester, New York, 14642, United States

North Carolina

Duke University, Durham, North Carolina, 27708, United States

Pennsylvania

University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15219, United States

Texas

MD Anderson Cancer Center, Houston, Texas, 77030, United States

Washington

Swedish Cancer Institute, Seattle, Washington, 98104, United States
University of Washington, Seattle, Washington, 98195, United States
Sanatorio Modelo Quilmes, Quilmes, B1878, Argentina
Chris O'Brien Lifehouse (COBL), Sydney, 2050, Australia
Ordensklinikum Linz GmbH, Linz, 4020, Austria
Medical University of Vienna Chirurgie, Vienna, 1090, Austria
Hospital de Base do Distrito Federal, Brasília, 70330-150, Brazil
Sirio Libanes Hospital Brasilia, Brasília, Brazil
Hospital Nossa Senhora das Graças, Curitiba, 80810-040, Brazil
Hospital Geral de Fortaleza, Fortaleza, 60150-160,, Brazil
Instituto do Cancer do Ceará, Fortaleza, 60430-230, Brazil
Instituto de Mastologia e Oncologia, Goiânia, 74110-060, Brazil
Hospital de Câncer Araújo Jorge, Goiânia, 74605-070, Brazil
Sirio Libanes Hospital, São Paulo, 01308-050, Brazil
Instituto D'OR de Pesquisa e Ensino, São Paulo, 01401-002, Brazil
Sir Mortimer B. Davis Jewish General Hospital, Montreal, H3T 1E2, Canada
Arturo Lopez Perez Foundation, Providencia, 7500921, Chile
Institute of Radiation Medicine, Vitacura, 7630370, Chile
Clinical Hospital Center Rijeka, Rijeka, 51000, Croatia
University Hospital Augsburg, Augsburg, 86156, Germany
University Hospital Düsseldorf, Düsseldorf, 40225, Germany
KEM | Clinics Essen-Mitte, Essen, 45136, Germany
University Hospital Heidelberg, Heidelberg, 69120, Germany
University Hospital Lübeck, Lübeck, 23562, Germany
University General Hospital of Heraklion, Heraklion, 71110, Greece
Athens Medical Center, Marousi, 151 25, Greece
Sheba Medical Center, Ramat Gan, Israel
Insituto Europeo di Oncologia, Milan, 20141, Italy
University Hospital Federico II, Napoli, 80131, Italy
IOV Padua, Padua, 35128, Italy
Clinici Scientifici Maugeri IRCCS, Pavia, 27100, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00136, Italy
Pauls Stradiņš Clinical University Hospital, Riga, LV-1002, Latvia
National Cancer Institute, Vilnius, 08406, Lithuania
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, 1066 CX, Netherlands
Oslo University Hospital, Oslo, N-0424, Norway
Dow University of Health Sciences, Karachi, Sindh 74200, Pakistan
Hospital Nacional Guillermo Almenara Irigoyen, La Victoria, 13, Peru
Instituto Nacional de Enfermedades Neoplasicas, Surquillo, 15038, Peru
University Hospital Zielona Gora, Zielona Góra, 65-046, Poland
Champalimaud Foundation, Lisbon, 1400-038, Portugal
N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, 197758, Russia
AGEL Mammacentrum sv. Agáty, Banská Bystrica, 974 01, Slovakia
Institute of Oncology Ljubljana, Ljubljana, 1000, Slovenia
ASAN Medical Center, Seoul, South Korea
Gangnam Severance Hospital, Seoul, South Korea
Samsung Medical Center, Seoul, South Korea
Seoul National University Hospital, Seoul, South Korea
Hospital del Mar d'Investigacions Mèdiques, Barcelona, 08003, Spain
Clinica Universidad de Navarra, Madrid, 28027, Spain
Hospital Universitario La Paz, ía Mamaria, Madrid, 28046, Spain
Capio Saint Göran's Hospital, Stockholm, 112 19, Sweden
Cantonal Hospital Baden, Baden, 5404, Switzerland
University Hospital Basel, Basel, 4031, Switzerland
Campus SLB Sonnenhof AG, Bern, 3001, Switzerland
Cantonal Hospital Luzern, Lucerne, 6000, Switzerland
EOC Centro di Senologia della Svizzera Italiana, Lugano, 6962, Switzerland
Tumor und Brustzentrum Ostschweiz, Sankt Gallen, 9016, Switzerland
Cantonal Hospital Winterthur, Winterthur, 8400, Switzerland
Zürich Breast Center, Zurich, 8008, Switzerland
University Hospital Zürich, Zurich, 8091, Switzerland
Gülhane Training and Research Hospital, Ankara, 06010, Turkey (Türkiye)
Istanbul University Faculty of Medicine, Fatih, 34093, Turkey (Türkiye)
Marmara University, Istanbul, Turkey (Türkiye)
Zonguldak Bülent Ecevit University, Zonguldak, 67100, Turkey (Türkiye)
Cambridge University Hospitals, Cambridge, CB2 0QQ, United Kingdom