A Phase III Study Evaluating of the Role of Axillary (Armpit) Lymph Node Removal in Patients with Breast Cancer with Positive Sentinel Lymph Nodes after Preoperative Chemotherapy

Protocol
14-151
Full Title
A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (Alliance A011202)
Phase
III
Disease Status
Newly Diagnosed
Purpose

Breast cancer can spread to lymph nodes under the arm (“axillary nodes”). Surgeons remove and examine the first lymph nodes to which cancer cells might spread (sentinel nodes) to determine the extent of cancer spread and to guide treatment. Removing many lymph nodes can sometimes cause a problem called lymphedema, in which fluid collects in the soft tissue of the affected arm, which can be uncomfortable. Surgeons therefore try to remove as few lymph nodes as possible while still providing the most effective care to treat a patient’s cancer.

In this study, researchers want to see if axillary radiation therapy is as effective as the standard treatment of removing the axillary nodes in patients who received chemotherapy before breast cancer surgery but who still have cancer cells in their sentinel nodes afterward. Patients with positive sentinel nodes after such “neoadjuvant” chemotherapy will be randomly assigned to one of two groups.

One group will have the standard treatment of having more axillary lymph nodes removed at the time of breast cancer surgery. The second group will have the investigational treatment, which is radiation therapy to the axillary lymph nodes without having more lymph nodes removed at the time of breast cancer surgery. Researchers will compare the two groups to see how well they do over a five-year period.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a biopsy showing cancer cells in the axillary lymph nodes before treatment begins.
  • Patients must have completed at least six cycles of chemotherapy before breast cancer surgery (for stage I-III disease) and still have cancer cells in their sentinel nodes afterward.
  • Patients may not have received preoperative radiation therapy or hormonal therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tari A King at 646-888-5432.

Disease(s)
Breast Cancer
Related Diseases