A Phase III Study of Hormone Therapy with and without Chemotherapy in Patients with HER2-Negative Breast Cancer and 1-3 Positive Lymph Nodes and a Recurrence Score of 25 or Less

Protocol
12-118
Full Title
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer (SWOG #S1007)
Phase
III
Purpose

The Oncoype DX test is used to determine a patient’s risk of breast cancer recurrence. It is often used to guide breast cancer treatment. For example, some women may benefit from chemotherapy, while others may not need it and can be spared from its side effects. The results of Oncotype DX may be used to help make this decision.

In this study, researchers are comparing the use of hormone therapy with and without chemotherapy in women whose breast cancers contain hormone receptors and are HER2-negative (making them ineligible for trastuzumab treatment), who also had one to three underarm lymph nodes containing cancer cells and whose Oncotype DX recurrence scores are 25 or less. Survival between the women who receive chemotherapy and those do not will be compared.

The researchers will see if the survival difference between the two groups corresponds to an Oncotype DX recurrence score which may serve as a cut-off point to determine whether or not a woman stands to benefit from chemotherapy. It is currently not know what this cut-off point may be among patients with recurrence scores of 25 or less.

Eligibility

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

  • Patients must have breast cancer that is hormone receptor-positive and HER2-negative and was surgically removed.
  • Patients must have had one to three axillary lymph nodes found to contain breast cancer cells.
  • Patients must have an Oncotype DX score of 25 or less.
  • Patients may not have had prior treatment with chemotherapy, hormonal therapy, or radiation therapy to the breast.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Diana Lake at 646-888-5444.

Disease(s)
Breast Cancer
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