BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.
Eligibility criteria
Qualifiers
Age ≥ 18 years of age at time of consent
ECOG 0, 1, or 2
Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3/N0-N1/M0 by physical exam or radiologic studies
Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as defined by ASCO/CAP guidelines)
Disqualifiers
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer.
Any type of breast implants
Active infection requiring systemic therapy
Uncontrolled HIV/AIDS or active viral hepatitis
Trial design
Treatments tested in this trial
- Azacitidine
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
1University of Illinois Cancer Center60612, ChicagoIllinois, United States
Sponsors and collaborators
University of Illinois at Chicago
Lead sponsor
Source ClinicalTrials.gov