DEBRA Trial: Skipping Radiation After Lumpectomy
Trial Details
Overview: The DEBRA Trial is investigating whether some people who have been diagnosed with stage I breast cancer may do just as well when treated with hormonal therapy alone after a lumpectomy compared to radiation and hormonal therapy after a lumpectomy. The trial is focused on people diagnosed with breast cancer that is:
hormone receptor positive, HER2 negative, and small (less than 2 centimeters)
has not spread to lymph nodes
has a low risk of coming back (recurring).
This information will be in your pathology report.
Phase: Phase III; phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large — some involve thousands of people — and are done at many places in the United States and around the world.
Number of people to enroll: 1,670
ClinicalTrials.gov ID number: NCT04852887
Sponsor of the trial: NRG Oncology
Collaborator: National Cancer Institute
Who is the trial for?
The DEBRA trial is enrolling adults who are between the ages of 50 and 70 years, were recently diagnosed with stage I breast cancer, and have had a recent lumpectomy but no other cancer treatment. To be eligible for the trial, participants had to have a score of 18 or lower on the Oncotype DX Breast Recurrencetest or Low on the MammaPrint test.
The Oncotype DX Breast Recurrence test and MammaPrint test are genomic tests. The Oncotype DX Breast Recurrence test is used for estrogen-receptor-positive, HER2-negative cancer, and it analyzes a sample of a cancer to see how active 21 specific genes are. The activity levels of these genes affect how the cancer behaves: this includes how likely it is to grow and spread, how likely it is to recur, and whether chemotherapy is likely to be useful. The MammaPrint test is similar, except that it checks the activity of 70 genes.
Why is the trial being done?
For many years, people diagnosed with early stage breast cancer have faced two main options: mastectomy or lumpectomy followed by radiation. There are side effects of radiation, and in recent years, researchers have started to ask whether there are people who might be able to skip radiation after lumpectomy. This study is designed to investigate whether some groups of people with cancers that are considered particularly low risk, based on their stage and their molecular and genetic characteristics, can have just as good an outcome without radiation therapy.
In the study, people will be assigned randomly to one of two groups:
One group will receive radiation therapy and then any one of several standard hormonal treatments, in pill form, for at least 5 years; there are three possible types of radiation therapy and four possible hormonal treatments, and people’s individual doctors can choose between them.
The second group will receive hormonal treatments only.
The researchers will track whether the study participants experience breast cancer recurrence for five years.
Specific eligibility requirements
People are eligible for the DEBRA study if they:
have been diagnosed with stage I breast cancer that is hormone receptor positive (estrogen receptor positive, progesterone receptor positive, or both), HER2 negative, and no bigger than 2 centimeters (about three-quarters of an inch)
have had an Oncotype DX Breast Recurrence genomic test and received a score of 18 or lower, or had a MammaPrint genomic test and received a score of Low
People are not eligible for DEBRA if they:
have had a mastectomy
have already had radiation therapy, chemotherapy, or biotherapy for this cancer
have been diagnosed with metastatic breast cancer, bilateral breast cancer (cancer in both breasts), or multicentric cancer (more than one tumor in separate parts of the breast that appear to have developed separately)
have been diagnosed with breast sarcoma, a rare type of breast cancer
have certain other conditions, such as dermatomyositis, lupus, or scleroderma
Learn about the additional eligibility requirements.
Side effects
The specific hormone therapy medicine(s) prescribed as part of this study will be chosen by the investigator(s). The possible medicines, all taken daily as pills, are tamoxifen or an aromatase inhibitor: Arimidex (anastrozole), Femara (letrozole), or Aromasin (exemestane).
The most common side effects of tamoxifen are:
The most common side effects of aromatase inhibitors are:
hot flashes
arthritis
depression
nausea
broken bones
Side effects of radiation can vary, but often include peeling skin, redness, and fatigue.
Study locations
The DEBRA study is being conducted at dozens of sites across the United States.
For more information or to enroll
Call Judy Langer, MD, MS, at 412-339-5300 or email langerj@nrgoncology.org.
— Last updated on August 30, 2024 at 10:01 PM