RECRUITING

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

Conditions

Breast Cancer Female Breast Cancer Invasive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-10

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04891068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years of age at time of consent 2. ECOG 0, 1, or 2 3. Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1c-T2/N0-N1/M0 by physical exam or radiologic studies. 4. 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) 1. HER2 positive (IHC or FISH) 2. Node positive 3. Any clinical high-risk expression profile (mammaprint, oncotype, endopredict) 4. PR negative (IHC) OR III. HER 2 positive (as defined by ASCO/ACP guidelines) f. Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration.	1. 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. 2. Any type of breast implants 3. Active infection requiring systemic therapy 4. Uncontrolled HIV/AIDS or active viral hepatitis 5. Pregnant or nursing 6. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist. 7. Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient. 8. Other major comorbidity, as determined by study PI

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years of age at time of consent
2. ECOG 0, 1, or 2
3. Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1c-T2/N0-N1/M0 by physical exam or radiologic studies.
4. 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)
1. HER2 positive (IHC or FISH)
2. Node positive
3. Any clinical high-risk expression profile (mammaprint, oncotype, endopredict)
4. PR negative (IHC) OR III. HER 2 positive (as defined by ASCO/ACP guidelines) f. Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration.

1. 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.
2. Any type of breast implants
3. Active infection requiring systemic therapy
4. Uncontrolled HIV/AIDS or active viral hepatitis
5. Pregnant or nursing
6. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
7. Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient.
8. Other major comorbidity, as determined by study PI

Contacts and Locations

Study Contact

VK Gadi, MD, PhD

CONTACT

312-996-1581

vkgadi@uic.edu

Mercedes Carrasquillo, BS

CONTACT

3124131902

micarras@uic.edu

Principal Investigator

Vijayakrishna Krishnamurthy Gadi, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Study Locations (Sites)

University of Illinois Cancer Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Vijayakrishna Krishnamurthy Gadi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-10

Study Completion Date2026-05

Study Record Updates

Study Start Date2022-01-10

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer Female
Breast Cancer Invasive