← Back to Search

Anti-metabolites

Low Dose Azacitidine for Early Stage Breast Cancer (BRE-04 Trial)

Phase 2
Recruiting
Led By Vijayakrishna Krishnamurthy Gadi, MD, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years of age at time of consent
ECOG 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

BRE-04 Trial Summary

This trial will look at how well a low dose of azacitidine therapy shrinks early stage breast cancer tumors by looking at the number of tumor-infiltrating lymphocytes before and after treatment.

Who is the study for?
This trial is for adults with high-risk early stage breast cancer that hasn't spread far and hasn't been treated yet. Eligible patients have tumors over 1cm, are not pregnant or breastfeeding, and can follow the study plan. They should be in good health overall without serious illnesses that could interfere with the trial.Check my eligibility
What is being tested?
The trial tests low dose Azacitidine's effect on immune cells within breast tumors. Researchers will compare these immune cell counts before and after treatment to see if there's a change.See study design
What are the potential side effects?
While specific side effects of low dose Azacitidine in this context aren't listed, common ones include nausea, fatigue, bruising or bleeding more easily due to lower blood cell counts, and increased risk of infection.

BRE-04 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My breast cancer is confirmed and at an early to mid-stage, without distant spread.
Select...
My breast cancer is triple-negative, ER-positive with high risk, or HER2-positive.
Select...
My breast tumor is larger than 1cm.
Select...
My cancer has not spread to distant parts of my body.

BRE-04 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in tumor infiltrating lymphocytes (TILs) count in primary tumors from patients with high-risk early stage breast cancer following low-dose azacitidine therapy.
Secondary outcome measures
Clinical response (change Ki67 and tumor size) of primary tumor following treatment with low dose azacitidine therapy
Disease Free Survival (DFS)
Overall Survival (OS)
+2 more

Side effects data

From 2007 Phase 3 trial • 358 Patients • NCT00071799
67%
Thrombocytopenia
65%
Neutropenia
50%
Constipation
48%
Nausea
48%
Anaemia
43%
Injection site erythema
29%
Injection site reaction
27%
Vomiting
26%
Pyrexia
24%
Fatigue
22%
Diarrhoea
19%
Nasopharyngitis
19%
Cough
18%
Injection site pain
18%
Leukopenia
17%
Acute myeloid leukaemia
15%
Asthenia
15%
Dyspnoea
15%
Epistaxis
14%
Headache
14%
Anorexia
13%
Oedema peripheral
12%
Abdominal pain
12%
Haematoma
11%
Febrile neutropenia
11%
Pneumonia
11%
Transfusion reaction
11%
Petechiae
11%
Pruritus
10%
Oral herpes
10%
Dizziness
10%
Rash
9%
Arthralgia
9%
Back pain
9%
Bronchitis
9%
Insomnia
9%
Upper respiratory tract infection
9%
Hypertension
8%
Weight decreased
8%
Contusion
7%
Haemorrhoids
7%
Erythema
7%
Urinary tract infection
7%
Lethargy
6%
Abdominal pain upper
6%
Muscle spasms
6%
Gingival bleeding
6%
Injection site rash
6%
Influenza
6%
Oral candidiasis
6%
Rhinitis
6%
Pain in extremity
6%
Hypotension
6%
Dyspepsia
6%
Injection site haematoma
6%
Hypokalaemia
6%
Haematuria
6%
Pharyngolaryngeal pain
5%
Chest pain
5%
Mouth ulceration
5%
Musculoskeletal pain
5%
Depression
5%
Oedema
5%
Pharyngitis
5%
Anxiety
5%
Ecchymosis
5%
Injection site bruising
5%
Injection site induration
5%
Dyspnoea exertional
4%
Pain
4%
Bone pain
4%
Alopecia
4%
Skin lesion
3%
Conjunctival haemorrhage
3%
Tachycardia
3%
Stomatitis
3%
Respiratory tract infection
3%
Productive cough
3%
Dry mouth
3%
Gingivitis
3%
Chills
3%
Sinusitis
3%
Sepsis
3%
Fall
3%
Alanine aminotransferase increased
3%
Sleep disorder
2%
Muscular weakness
2%
Neutropenic sepsis
2%
Catheter site haematoma
2%
Hyperuricaemia
2%
Gastritis
2%
Nasal congestion
2%
Purpura
2%
Cardiac failure
2%
Bronchopneumonia
2%
Lymphopenia
2%
Gastrooesophageal reflux disease
2%
Rectal haemorrhage
2%
General physical health deterioration
2%
Pallor
2%
Septic shock
2%
Myelodysplastic syndrome
2%
Cerebral haemorrhage
2%
Pitting oedema
2%
Procedural pain
2%
Syncope
1%
Myocardial infarction
1%
Strabismus
1%
Haematemesis
1%
Mouth haemorrhage
1%
Endophthalmitis
1%
Gastrointestinal haemorrhage
1%
Salmonella sepsis
1%
Benign prostatic hyperplasia
1%
Tooth disorder
1%
Haemorrhoidal haemorrhage
1%
Blood lactate dehydrogenase increased
1%
Fungal skin infection
1%
Subileus
1%
Hypophosphataemia
1%
Joint swelling
1%
Intestinal haemorrhage
1%
Angina pectoris
1%
Angle closure glaucoma
1%
Atrial fibrillation
1%
Eye Haemorrhage
1%
Pancytopenia
1%
Food poisoning
1%
Ventricular tachycardia
1%
Gastrointestinal pain
1%
Conjunctivitis
1%
Transient ischaemic attack
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Oral soft tissue disorder
1%
Perianal abscess
1%
Delirium
1%
Corynebacterium infection
1%
Lung infection
1%
Tooth abscess
1%
Confusional state
1%
Abdominal discomfort
1%
Hypoxia
1%
Psychotic disorder
1%
Herpes zoster
1%
Subcutaneous abscess
1%
Subdiaphragmatic abscess
1%
Anal haemorrhage
1%
Meningitis
1%
Renal colic
1%
Ocular hyperaemia
1%
Catheter site haemorrhage
1%
Catheter site pain
1%
Enterobacter infection
1%
Musculoskeletal chest pain
1%
Peripheral vascular disorder
1%
Pulmonary embolism
1%
Pleural effusion
1%
Cardiac failure acute
1%
Vertigo
1%
Oesophageal carcinoma
1%
Myopia
1%
Retinal artery occlusion
1%
Squamous cell carcinoma of skin
1%
Haemoptysis
1%
Lung infiltration
1%
Respiratory failure
1%
Pulmonary oedema
1%
Pulmonary fibrosis
1%
Hallucination
1%
Colitis ulcerative
1%
Injection site nodule
1%
Bacteraemia
1%
Bile duct stone
1%
Hepatic function abnormal
1%
Fungal sepsis
1%
Gasteroenteritis
1%
Gasteroenteritis salmonella
1%
Laryngopharyngitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection
1%
Pulmonary tuberculosis
1%
Sialoadenitis
1%
Splenic abscess
1%
Staphylococcal bacteraemia
1%
Clavicle fracture
1%
Hip fracture
1%
Traumatic intracranial haemorrhage
1%
Diabetes mellitus
1%
Colon cancer
1%
Lung adenocarcinoma
1%
Neoplasm prostate
1%
Urinary tract neoplasm
1%
Coma
1%
Haemorrhage intracranial
1%
Renal failure
1%
Urethral stenosis
1%
Acute pulmonary oedema
1%
Acute respiratory failure
1%
Hypoalbuminaemia
1%
Hyponatraemia
1%
Lymphadenopathy
1%
Gingival pain
1%
Generalised oedema
1%
Catheter related infection
1%
Neck pain
1%
Dermatitis allergic
1%
Rash macular
1%
Urticaria
1%
Bone marrow failure
1%
Pericardial effusion
1%
Hypothyroidism
1%
Retinal Haemorrhage
1%
Retinal tear
1%
Abdominal wall abscess
1%
Abscess neck
1%
Ear infection
1%
Enterobacter bacteraemia
1%
Mucormycosis
1%
Neutropenic infection
1%
Parotitis
1%
Pneumonia fungal
1%
Synovial rupture
1%
Osteoporosis
1%
Myelofibrosis
1%
Loss of consciousness
1%
Urinary retention
1%
Pneumonitis
1%
Actinic keratosis
1%
Aortic aneurysm
1%
Circulatory collapse
1%
Bronchopulmonary aspergillosis
1%
Bradycardia
1%
Aphthous stomatitis
1%
Mucosal inflammation
1%
Staphylococcal infection
1%
Viral upper respiratory tract infection
1%
Scratch
1%
Thermal burn
1%
Aspartate aminotransferase increased
1%
Hypocalcaemia
1%
Bursitis
1%
Sinus headache
1%
Chromaturia
1%
Proteinuria
1%
Pleurisy
1%
Rash papular
1%
Rash pruritic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine
Low-dose Cytarabine
Best Supportive Care Only
Standard Chemotherapy

BRE-04 Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm with previously untreated high risk early stage breast cancerExperimental Treatment1 Intervention
All participants will receive azacitidine 50mg/m2 SC daily for five consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
608 Previous Clinical Trials
1,559,465 Total Patients Enrolled
11 Trials studying Breast Cancer
1,342,356 Patients Enrolled for Breast Cancer
Vijayakrishna Krishnamurthy Gadi, MD, PhDPrincipal Investigator - University of Illinois at Chicago
University of Illinois at Chicago

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04891068 — Phase 2
Breast Cancer Research Study Groups: Single arm with previously untreated high risk early stage breast cancer
Breast Cancer Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04891068 — Phase 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891068 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been included in this clinical trial thus far?

"Affirmative. Per the clinicaltrials.gov registry, this scientific examination is currently accepting participants. It was initially posted on January 10th 2022 and last revised April 22nd of that same year. They are looking for 40 individuals to be recruited from one medical facility."

Answered by AI

Has recruitment for this clinical endeavor been opened up to the public yet?

"According to clinicaltrials.gov, this research is actively recruiting test subjects. The initial posting was on October 10th 2022 and the information has been amended as recently as April 22nd 2022."

Answered by AI

Has Azacitidine been tested in any other clinical studies?

"Currently, there are 174 Azacitidine trials in progress; 32 of them have progressed to Phase 3. To access these studies, patients may travel to Saint Louis, Missouri or visit one of the 5671 locations hosting clinical trials for this medication."

Answered by AI

What ailments is Azacitidine typically administered to address?

"Azacitidine is primarily prescribed to treat malignant neoplasms; however, it can also be used when patients experience 20-30% blasts in their blood, neutropenia and/or thrombocytopenia as well as anemia."

Answered by AI

Are there any adverse effects to utilizing Azacitidine as a treatment?

"Our team at Power gave Azacytidine a 2 on the safety scale, as it is currently in its second phase of clinical trials. There has been some data collected to support its security, but none validating efficacy yet."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Vijayakrishna Krishnamurthy Gadi 2022. "BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04891068.
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top