Molecular Test to Personalize Breast Cancer Treatment

A new genetic test is designed to assess whether a breast tumor will respond to therapy, thereby identifying more precisely those patients who can be adequately treated with hormonal therapy and those patients who need both chemotherapy and hormonal therapy.

The test, called OncotypeDX, was developed by Genomic Health, Inc. (Redwood, CA, USA), in collaboration with the U.S. National Surgical Adjuvant Breast and Bowel Project, a network of cancer research professionals. The test identifies which of 21 specific genes are turned on or off in the tumor. This assessment estimates a patient's risk of recurrence more precisely than tumor size and grade and also helps predict if the patient will benefit from chemotherapy.

A clinical trial called TAILOR (Trial Assigning Individualized Options for Treatment), sponsored by the U.S. National Cancer Institute, will enroll 10,000 women with breast cancer at more than 900 institutions throughout the United States and Canada. Participating women will be assigned to one of three groups depending on their recurrence score. If the score is more than 25, women will receive chemotherapy plus hormonal therapy, the current standard of care. If it is less than 11, they will receive hormonal therapy alone. If the recurrence score is between 11 and 25, women will be randomized to receive either hormonal therapy or hormonal therapy together with chemotherapy.

"With better individualized treatment, we can spare women the side effects of chemotherapy where it is unnecessary,” said Dr. Joseph Sparano, who directs the Breast Evaluation Center at the Montefiore-Einstein Cancer Center in New York (NY, USA). Dr. Sparano will be the lead investigator in the trial. "With this trial, we're taking a big leap forward in integrating modern molecular diagnostic testing into clinical decision-making in order to individualize cancer treatments.”



Related Links:
Genomic Health
Montefiore-Einstein Cancer Center