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BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer

ConditionsBreast Cancer InvasiveEarly-stage Breast CancerHigh Risk Breast Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Azacitidine

    Drug

    5-Azacitidine is a pyrimidine nucleoside analog in which nitrogen replaces carbon at position 5

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single arm with previously untreated high risk early stage breast cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in tumor infiltrating lymphocytes (TILs) count in primary tumors from patients with high-risk early stage breast cancer following low-dose azacitidine therapy.

Number of participants that show tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer

Time frame
2 weeks from first dose of azacitidine

Secondary outcomes

1

Clinical response (change Ki67 and tumor size) of primary tumor following treatment with low dose azacitidine therapy

Number of participants that have a clinical response at time of surgery based on changes in the Ki-67 index

Time frame
2 weeks from first dose of azacitidine
2

Safety - completion rate of low-dose azacitidine

Number of participants that fail to complete the planned course of treatment intervention using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5

Time frame
30 days after last dose of azacitidine
3

Safety - tolerability of low-dose azacitidine therapy assessed by using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5

Number of participants that have treatment related adverse events using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5

Time frame
30 days after last dose of azacitidine
4

Disease Free Survival (DFS)

Number of days participants had DFS

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
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