Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

Conditions

• Stage II Breast Cancer
• Stage IIIA Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Axillary Lymph Node Dissection (ALND) — PROCEDURE
• Nodal Radiation Therapy — RADIATION
• Axillary Radiation Therapy — RADIATION

Study Details

This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

Key Dates

First listed

Jul 17, 2013

Start date

Feb 24, 2014

Status verified

Aug 2026

Primary completion

Jan 31, 2031

Completion

Jan 31, 2031

Study Design

Enrollment

2,012 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Arm 1: ALND + nodal radiation therapy
  Surgery: For patients randomized to axillary lymph node dissection (ALND), it is recommended that a complete level I and II dissection with resection of minimum of a total of 8 lymph nodes (SLN and ALND together) be done. Level III dissection is not required, but may be performed at the discretion of the surgeon. If fewer than 8 lymph nodes (SLN and ALND together) are resected, then the patient will discontinue protocol treatment. Radiation Therapy: Radiation is delivered to the breast/chest wall, undissected axilla, supraclavicular nodes and internal mammary nodes in the first 3 intercostal spaces. Treatment will be given 5 days a week over 5-6 weeks.
• Other: Arm 2: Axillary radiation and nodal radiation therapy
  Radiation Therapy: Radiation is delivered to the breast/chest wall, full axilla including Levels I, II, III, supraclavicular nodes and internal mammary nodes in the first 3 intercostal spaces. Treatment will be given 5 days a week over 5-6 weeks.

Primary Outcome Measure

Invasive breast cancer recurrence-free interval (IBC-RFI) [ Time Frame: Up to 8 years after completion of radiation therapy ]

Locations (1228)