RecruitingNot ApplicableNCT07140172

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery: An International, Randomized Superiority Trial (OPBC-10/ NOAX)

Sponsor

University Hospital, Basel, Switzerland

Enrollment

1,060 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for managing lymph nodes in the armpit (axilla) in breast cancer patients who have confirmed cancer in the lymph nodes: axillary lymph node dissection (surgical removal of many nodes) versus axillary radiotherapy (targeted radiation). The goal is to see if radiation can be as effective as surgery with fewer side effects. **You may be eligible if...** - You are 18 years or older - You have breast cancer (stage II or III) with confirmed cancer in armpit lymph nodes (confirmed by biopsy or pathology) - Your lymph node involvement was detected by imaging or is clinically palpable - You are scheduled for axillary surgery (sentinel lymph node procedure or full dissection) **You may NOT be eligible if...** - You have received neoadjuvant (pre-surgery) treatment and the lymph node status has changed - You have had prior radiation to the same breast or armpit area - You have inflammatory breast cancer - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAxillary lymph node dissection (ALND)

Surgical removal of lymphatic tissue within the anatomical boundaries of the axilla (standard of care in the upfront surgery setting in patients with cN+ BC)

PROCEDUREAxillary radiotherapy (ART)

Axillary irradiation

Locations(36)

Duke University/Duke Cancer Center

Durham, North Carolina, United States

Sanatorio Parque Breast Cancer Center

Rosario, Argentina

KH Dornbirn

Dornbirn, Austria

LKH Feldkirch

Feldkirch, Austria

MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

Innsbruck, Austria

CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal

Montreal, Canada

Breast Centre of Clinical Hospital, Rijeka

Rijeka, Croatia

HRUHC Sestre milosdrnice, Zagreb

Zagreb, Croatia

Brustzentrum Heidelberg Klinik St. Elisabeth GmbH

Heidelberg, Germany

HELIOS Universitätsklinikum Wuppertal

Wuppertal, Germany

"Alexandra" Hospital, Athens

Athens, Greece

University Hospital of Heraklion

Heraklion, Greece

University Hospital of Larissa

Larissa, Greece

Policlinico Universitario "Agostino Gemelli

Rome, Italy

Gangnam Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Kantonsspital Baden

Baden, Switzerland

Breast Surgery Service, University Hospital Basel

Basel, Switzerland

Clinique des Grangettes

Chêne-Bougeries, Switzerland

Spital Thurgau

Frauenfeld, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Clinique de Genolier

Genolier, Switzerland

Hirslandenklinik St. Anna

Lucerne, Switzerland

Kantonsspital Luzern

Lucerne, Switzerland

Centro di Senologia della Svizzera Italiana

Lugano, Switzerland

Hôpital Neuchâtelois

Neuchâtel, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Tumor-& Brustzentrum Ostschweiz St. Gallen

Sankt Gallen, Switzerland

Spital Limmattal

Schlieren, Switzerland

Hôpital du Valais, Hôpital de Sion

Sion, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Spital Zollikerberg

Zollikerberg, Switzerland

Brustzentrum Zürich (Seefeld)

Zurich, Switzerland

Stadtspital Triemli

Zurich, Switzerland

İstanbul Bağcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT07140172

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