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De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III Clinical Trial evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score Less than or Equal to 18: The DEBRA Trial
 
Region Sponsors
Mid-Atlantic
National Cancer Institute (NCI)
NRG Oncology
 
Acronym KP IRB No.
DEBRA 1827871
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Patients with breast cancer that is hormone sensitive and HER2-negative
 
Purpose
The purpose of this study is to see whether breast conservation surgery and endocrine therapy results in a rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) that is not worse than breast conservation with breast radiation and endocrine therapy.
 
Detailed Description
This is a phase III randomized 1:1 controlled clinical trail that will evaluate patients with pT1N0M0, ER and/ or PR-postitive, HER2- negative, oncotype recurrence score = 18 breast cancer who undergo breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery with breast radiation and endocrine therapy.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Breast cancer that is ER and/or PgR positive, and HER2-negative
  • 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 resection.)
  • Ipsilateral nodes must be pN0
  • The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.
 
Exclusion Criteria
  • Definitive clinical or radiologic evidence of metastatic disease
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry
  • Current therapy with any endocrine therapy
  • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
  • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, MS
-Leslie.K.Greenberg@kp.org
-Gaithersburg Medical Center


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