A Phase II Study of Breast-Conserving Surgery without Radiotherapy for Women with Breast Cancer: the PRECISION Trial

Share
Print

Full Title

The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer.

Purpose

Radiation therapy after breast-conserving surgery (lumpectomy) has long been the standard treatment for early-stage invasive breast cancer. However, some women ages 50-75 may be able to safely forego radiation therapy after surgery, sparing them from the side effects and inconvenience of this treatment. In this study, researchers are using a genetic test called Prosigna to determine the risk of recurrence in women with early-stage invasive breast cancer having lumpectomy and using the results to make decisions about radiation treatment after surgery.

Women whose risk of cancer recurrence is low will be offered the choice of having radiation therapy after surgery or foregoing this treatment. Women with an intermediate or high risk of recurrence will have radiation therapy. All patients in this study will be followed for up to ten years (at least five) and the results compared between the groups to determine if it is indeed feasible and safe for some patients with early-stage breast cancer to forego radiation therapy after lumpectomy.

Eligibility

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

  • Patients must be women with early-stage invasive breast cancer that is removed via lumpectomy and has not invaded nearby lymph nodes.
  • Patients may not have received prior chemotherapy, biologic therapy, or radiation therapy to the chest. Patients may have had up to 3 months of hormonal therapy.
  • Patients’ tumors may be no larger than 2 cm in diameter.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women ages 50-75.

For more information about this study and to inquire about eligibility, please contact Dr. Lior Braunstein at 201-775-7446.

Protocol

18-099

Phase

II

Investigator

Co-Investigators

Diseases