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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Axillary lymph node dissection (ALND) — PROCEDURE
  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)
• Axillary radiotherapy (ART) — PROCEDURE
  Axillary irradiation

Study Details

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.

Key Dates

Start date

Jan 1, 2026

Status verified

May 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2037

Study Design

Enrollment

1,060 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (Control): ALND
  1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes. 2. Surgery: ALND - current standard of care, with the intention to remove the entire soft tissue within the anatomical borders of the axilla. 3. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).
• Active Comparator: Arm B (Investigational): ART
  1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes. 2. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).TAS + breast/chest wall and axillary irradiation (ART) 3. Radiotherapy: Axillary radiotherapy (ART).

Primary Outcome Measure

Change in arm-related Quality of Life (QoL) [ Time Frame: From baseline to 2 years after randomization ]

Central Contacts

• Walter P. Weber, Prof. Dr. med.
  +41 61 328 61 49
  [email protected]
• OPBC project management team
  +41 61 55 65134
  [email protected]

Locations (4)

Find similar trials in Bethesda, MD

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