A Study Assessing Omission of Radiotherapy after Lumpectomy in Postmenopausal Women with Low-Risk Early-Stage Breast Cancer

Full Title

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone) A Prospective, Single-Arm Cohort Study of Patients Receiving Endocrine Therapy Alone (Without Radiotherapy) After Breast Conserving Surgery For Early-Stage, Post-Menopausal Breast Cancer Patients Whose Tumors Have Favorable Biologic Features

Purpose

Radiation therapy is often given after lumpectomy in women with early-stage breast cancer to reduce the risk of the cancer coming back. In some women, however, the risk of cancer recurrence is already quite low. Doctors are interested in learning if postmenopausal women who had a lumpectomy for early-stage breast cancer that has a low risk of coming back can safely forego radiation therapy and just take hormonal therapy instead. That is the purpose of this study.

Women in this study will take tamoxifen or an aromatase inhibitor (which are taken orally) after breast cancer surgery, and will not have radiation therapy. They'll continue to be monitored by their doctors.

Eligibility

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

  • Patients' tumors must test positive for estrogen and progesterone receptors and be negative for HER2.
  • This study is for postmenopausal women ages 50 to 69.
  • Patients must have a 2 cm or smaller tumor with negative lymph nodes and a low Oncotype-DX score (18 or less), indicating it has a low chance of coming back.
  • Patients must be treated with or have already had a lumpectomy with negative margins, but no prior radiation therapy to the breast.
  • Patient must be willing to take hormonal treatment (an aromatase inhibitor) for at least five years.

For more information about this study and to inquire about eligibility, please contact Dr. Mahmoud El-Tamer at 646-888-4755.

Protocol

15-167

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

Diseases