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Radiation and Endocrine Therapy for Breast Cancer(DEBRA Trial)
DEBRA Trial Summary
This trial is testing whether a combination of surgery and hormone therapy is non-inferior to surgery, hormone therapy, and radiation for treating breast cancer.
- Breast Cancer
DEBRA Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
DEBRA Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
DEBRA Trial Design
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Who is running the clinical trial?
- The patient must be in good physical condition.Pathologic staging of pN0(i+) or pN0(mol+) patients are NOT eligible for this study.Patients with a T1a tumor who do not already have an Oncotype DX Recurrence Score at study entry must send a specimen to the Genomic Health centralized laboratory.The Oncotype DX Recurrence Score is less than or equal to 18 on a diagnostic core biopsy or resected specimen.The patient must have had a lumpectomy and the margins of the resected specimen or re-excision must have been histologically free of invasive tumor and DCISAJCC
The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: By pathologic evaluation, the primary tumor must be classified as pT1 (less than or equal to 2 cm).
- Group 1: Arm 1: Breast Radiation Therapy + Endocrine Therapy
- Group 2: Arm 2: No Breast Radiation Therapy + Endocrine Therapy
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research project only seeking volunteers who are under 45 years old?
"This particular trial is only looking for patients aged 50 to 70. Out of the 3,633 clinical trials available, 239 are specific for children and adolescents while 3,394 focus on elderly patients."
Are there any similar cases to Arm 2 in which no breast radiation therapy was combined with endocrine therapy?
"The research team at Queen Mary University of London first began studying Arm 2: No Breast Radiation Therapy + Endocrine Therapy in 1994. In terms of global clinical trial activity, 434 have completed while 235 are ongoing. The city with the most active clinical trials is Chicago, Illinoiso Breast Radiation Therapy + Endocrine Therapy in 1994. In terms of global clinical trial activity, 434 have completed while 235 are ongoing. The city with the most active clinical trials is Chicago, Illinois."
Do the benefits of Arm 2: No Breast Radiation Therapy + Endocrine Therapy outweigh the risks for patients?
"Arm 2: No Breast Radiation Therapy + Endocrine Therapy receives a safety score of 3 from Power. This is indicative of strong safety data, as it comes from a Phase 3 trial which means that there is both efficacy and multiple rounds of supportive safety data."
Is this clinical trial only taking place in the United States?
"There are many sites associated with this trial, but some of the notable ones include Northwestern University in Chicago, Illinois; Capital Health Medical Center-Hopewell in Pennington, Wisconsin; and Cancer Care Specialists of Illinois - Decatur in Decatur, Coloradogo, Illinois; Capital Health Medical Center-Hopewell in Pennington, Wisconsin; and Cancer Care Specialists of Illinois - Decatur in Decatur, Colorado."
Who does this trial hope to attract as participants?
"This clinical trial is looking for 1670 breast cancer patients between the ages of 50 and 70. Candidates must meet the following criteria: The patient must have an ECOG performance status of 0 or 1, The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional rese"
How many individuals are able to enroll in this research project?
"In order to obtain accurate results, 1670 patients must participate in this trial and meet the pre-defined eligibility criteria. These individuals can enrol at various sites, such as Northwestern University located in Chicago, Illinois or Capital Health Medical Center-Hopewell situated in Pennington, Wisconsin, Illinois or Capital Health Medical Center-Hopewell situated in Pennington, Wisconsin."
What is the Arm 2: No Breast Radiation Therapy + Endocrine Therapy protocol typically used to manage?
"Arm 2 of this clinical trial will test the efficacy of forgoing radiation therapy and instead relying on endocrine therapy. This approach is most often used to treat aggressive neoplasms, but has also shown some success in treating ovarian cancer, tamoxifen-resistance, and high risk patients."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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