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Study Aims to Find Which Breast Cancer Patients Need Chemotherapy

because its efficacy was studied in a relatively small number of women and it costs several thousand dollars, says Dr. Samuel, who used the test only twice before the study.

If the federally funded study of thousands of women over the next five-plus years backs up smaller studies, the test likely will become part of the standard of care for this group of women, he says.

The Trial Assigning Individualized Options for Treatment, or TAILORx trial, coordinated by the Eastern Oncology Group, is the first study resulting from the National Cancer Institute’s Program for the Assessment of Clinical Cancer Tests.

Enrollees with the lowest recurrence scores will have radiation therapy and hormonal treatment following lumpectomy. Those with the highest will also get chemotherapy. “The debate is in the intermediate risk group. That is where most women fall and the ones where we are not really sure what to do,” Dr. Samuel says. That majority of patients will be randomized to either get chemotherapy or not.

Dr. Samuel hopes to enroll about two patients per month; the trial likely will be open several years depending on how long it takes to get a total of 10,000 nationally. Participants will be followed for at least five years.

He notes the highest risk for recurrence is within two years after diagnosis. While the risk never goes away, it is very low after the five-year mark.

Breast cancer is most common in postmenopausal women and chemotherapy, tends to cause even more problems in older women, Dr. Samuel notes.

In fact, in this group of patients hormonal therapy is probably better tolerated and more efficacious, he says. Any patient who has a lumpectomy needs radiation therapy on remaining breast tissue. “We add chemotherapy if the tumor is big enough and we think the risk is high enough that the cancer may come back,” says Dr. Samuel. Chemotherapy must precede radiation therapy because it worse
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