What is the mechanism of action of this treatment?

Common treatments for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, hormone therapy blocks hormones that fuel certain cancers, targeted therapy attacks specific cancer cell molecules, and immunotherapy boosts the immune system to fight cancer. Low dose azacitidine, an epigenetic modulator, works by altering the expression of genes involved in cancer progression. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics, potentially improving outcomes and minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving epigenetic modulation like low-dose azacitidine, include hypomethylating agents and other chemotherapeutic drugs. The known side effects of these treatments can include cytopenias (reduction in blood cell counts), febrile neutropenia (fever with low white blood cell count), gastrointestinal symptoms (nausea, vomiting, diarrhea), fatigue, and potential liver and kidney function abnormalities. Patients may also experience increased susceptibility to infections and require hospitalization for neutropenic fever. Growth factor support and dose adjustments are often necessary to manage these side effects.

What prior FDA approvals exist?

Currently, there are no specific FDA approvals for the use of low-dose azacitidine or similar epigenetic modulation therapies in the treatment of breast cancer. The trial mentioned is investigating the potential of low-dose azacitidine in high-risk early-stage breast cancer, focusing on its effect on tumor-infiltrating lymphocytes. Broadly, FDA-approved treatments for breast cancer include hormone therapies (e.g., tamoxifen, aromatase inhibitors), chemotherapy (e.g., doxorubicin, paclitaxel), targeted therapies (e.g., trastuzumab, pertuzumab), and immunotherapies (e.g., pembrolizumab).

What other types of research exist?

Promising novel alternatives to Low Dose Azacitidine for breast cancer patients include targeted therapies such as PARP inhibitors (e.g., olaparib, talazoparib) for BRCA-mutated cancers, CDK4/6 inhibitors (e.g., palbociclib, ribociclib) for HR-positive, HER2-negative breast cancer, and immunotherapy agents like pembrolizumab for PD-L1 positive triple-negative breast cancer. Additionally, antibody-drug conjugates such as trastuzumab deruxtecan for HER2-positive breast cancer are also emerging as effective treatments.

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Anti-metabolites

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

Chicago, IL

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

Must not have

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

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if low dose azacitidine can help the immune system fight high-risk early stage breast cancer. The treatment aims to increase immune cells that attack cancer cells. It targets patients whose cancer is more likely to return or spread.

See full description

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My breast cancer is confirmed and at an early to mid-stage, without distant spread.

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My breast cancer is triple-negative, ER-positive with high risk, or HER2-positive.

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My breast tumor is larger than 1cm.

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My cancer has not spread to distant parts of my body.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments like chemotherapy or radiation for my current breast cancer.

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I am currently on medication for an infection.

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I do not have uncontrolled HIV/AIDS or active hepatitis.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 2024 Phase 2 & 3 trial • 76 Patients • NCT03092674

52%

White blood cell decreased

48%

Anemia

48%

Anorexia

44%

Lymphocyte count decreased

44%

Platelet count decreased

44%

Hypoalbuminemia

40%

Creatinine increased

40%

Neutrophil count decreased

36%

Hyponatremia

36%

Hyperglycemia

32%

Fatigue

32%

Hypophosphatemia

32%

Febrile neutropenia

28%

Hypokalemia

28%

Sepsis

28%

Constipation

28%

Aspartate aminotransferase increased

24%

Nausea

24%

Rash maculo-papular

20%

Alanine aminotransferase increased

20%

Hyperkalemia

20%

Cough

20%

Lung infection

20%

Diarrhea

20%

Dyspnea

16%

Hypotension

16%

Edema limbs

16%

Injection site reaction

16%

Blood bilirubin increased

16%

Pain in extremity

16%

Dizziness

16%

Pruritus

16%

Hypertension

16%

Gastrointestinal disorders-Other

16%

Alkaline phosphatase increased

16%

Weight loss

12%

Infections and infestations-Other

12%

Hyperuricemia

12%

Hypocalcemia

12%

Confusion

12%

Respiratory failure

12%

Mucositis oral

12%

Serum amylase increased

12%

Insomnia

Fever

Neoplasms benign, malignant and unspecified - Other

Blood and lymphatic system disorders-Other

Dry mouth

Vomiting

Gait disturbance

Skin infection

Upper respiratory infection

INR increased

Hypermagnesemia

Hypernatremia

Arthralgia

Generalized muscle weakness

Peripheral sensory neuropathy

Skin and subcutaneous tissue disorders-Other

Myocardial infarction

Acidosis

Hypothyroidism

Abdominal pain

Pain

Bruising

Headache

Urinary frequency

Epistaxis

Hypoxia

Pleural effusion

Disseminated intravascular coagulation

Acute kidney injury

Urinary retention

Cardiac disorders-Other

Chills

Fall

Electrocardiogram QT corrected interval prolonged

Hypomagnesemia

Myalgia

Dry skin

Heart failure

Supraventricular tachycardia

Leukocytosis

Cardiac arrest

Lower gastrointestinal hemorrhage

Death NOS

Infusion related reaction

Multi-organ failure

Sudden death NOS

Immune system disorders-Other

Activated partial thromboplastin time prolonged

Cardiac troponin I increased

Ejection fraction decreased

Fibrinogen decreased

Dehydration

Hypoglycemia

Pneumonitis

Sinus tachycardia

Blurred vision

Eye disorders-Other

General disorders and administration site conditio

Urinary tract infection

Hypercalcemia

Hematuria

Urinary urgency

Respiratory, thoracic and mediastinal disorders-Ot

100%

80%

60%

40%

20%

Study treatment Arm

Azacitidine + Nivolumab

Azacitidine

Azacitidine +Midostaurin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2014

Completed Phase 3

~1470

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, hormone therapy blocks hormones that fuel certain cancers, targeted therapy attacks specific cancer cell molecules, and immunotherapy boosts the immune system to fight cancer. Low dose azacitidine, an epigenetic modulator, works by altering the expression of genes involved in cancer progression. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics, potentially improving outcomes and minimizing side effects.

Indications and limitations of third-generation aromatase inhibitors.Gemcitabine.