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

  • STATUS
    Recruiting
  • participants needed
    1660
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 22 November 2020
Investigator
Marvin J. Feldman
Primary Contact
Northwest Hospital Center (3.8 mi away) Contact
+690 other location
breast surgery
estrogen
carcinoma
non-melanoma skin cancer
endocrine therapy
progesterone
anthracyclines
metastasis
hormone therapy
pertuzumab
tumor cells
carcinoma in situ
lobular carcinoma
trastuzumab
her-2
skin carcinoma
progesterone receptor
erbb2
estrogen receptor
invasive breast cancer
mastectomy
lumpectomy
ductal carcinoma in situ
axillary lymph node dissection
lobular carcinoma in situ
sentinel node
ductal carcinoma

Summary

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.

Description

PRIMARY OBJECTIVE:

I. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive sentinel lymph node(s) (SLN[s]) after completion of neoadjuvant chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.

II. To obtain an estimate of the distribution of residual disease burden scores.

III. To estimate the distribution of overall survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo axillary lymph node dissection. Beginning 3-12 weeks following surgery, patients undergo nodal radiation therapy comprising 3-dimensional (3D) conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), or proton radiation therapy (PRT) 5 days a week for 5-6 weeks.

ARM II: Patients undergo axillary and nodal radiation therapy comprising 3D-CRT, IMRT, or PRT 5 days a week for 5-6 weeks.

After completion of study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years.

Details
Treatment Axillary Lymph Node Dissection (ALND), Nodal Radiation Therapy, Axillary Radiation Therapy
Clinical Study IdentifierNCT01901094
SponsorAlliance for Clinical Trials in Oncology
Last Modified on22 November 2020

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