Clinical trial · Interventional
Azacitidine in Treating Patients With Triple Negative Stage I-IV Invasive Breast Cancer That Can Be Removed By Surgery
A Pilot Clinical Trial to Evaluate the Biological Activity of 5-azacitidine on ER and PR Expression in Triple Negative Invasive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual last 2 years
Summary
Brief summary (as posted)
This clinical trial studies azacitidine in treating patients with triple negative stage I-IV invasive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azacitidine | Drug | Azacitidine | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| nucleic acid sequencing | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| western blotting | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- See Detailed Description
- interventionNames
- Drug: azacitidine
- Other: laboratory biomarker analysis
- Other: immunohistochemistry staining method
- Genetic: polymerase chain reaction
- Genetic: western blotting
- Genetic: nucleic acid sequencing
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Percent of participants with ER/PR response after receiving 10 doses of 5-Azacitidine
- timeFrame
- 6 months after enrollment of last patient
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable tumor measuring 2 cm or more * Histologically documented triple negative invasive breast cancer characterized by 0% Immunohistochemistry (IHC) nuclear staining for ER-alpha, 0% IHC nuclear staining for PR-alpha, and no amplification of HER2/neu by fluorescence in situ hybridization (FISH); standard IHC assays for ER and PR use antibodies to ER-alpha and PR-alpha and PR-beta * Southwest Oncology Group (SWOG) performance status of less than or equal to 1 * Absolute neutrophil count (ANC) \>= 1500/μL * Hemoglobin (Hgb) \>= 9 g/dL * Platelets \>= 100,000/uL * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvate transaminase (SGPT) =\< 2.5 x upper limit normal (ULN) or =\< 5.0 x ULN in patients with liver metastases * Creatinine =\< 2.0 mg/dL Or Calculated Creatinine Clearance \>= 50 ml/min * Albumin \>= 3 g/dL * Potassium \>= lower limit normal (LLN) * Phosphorous \>= LLN * Calcium \>= LLN * Magnesium \> LLN * Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment * Accessible for treatment and follow-up * Written informed consent prior to study entry Exclusion Criteria: * HER2/neu amplification by FISH * Concurrent neoadjuvant treatment with chemotherapy, endocrine therapy, or radiotherapy * Known hypersensitivity to azacitidine or mannitol * Preexisting hepatic impairment or renal impairment * Intent to receive additional neoadjuvant therapy prior to surgery * Concurrent use of an histone deacetylase (HDAC) inhibitor or hydralazine * Known diagnosis of human immunodeficiency virus (HIV) infection * Major surgery \< 4 weeks prior to starting study drug * Pregnant or breastfeeding or female of reproductive potential not using an effective method of birth control * Other concurrent severe, uncontrolled infection or intercurrent illness, including but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements * Prior antiestrogens (selective estrogen receptor modulator \[SERM\] or aromatase inhibitors) within 6 months of study entry * Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment
References
Publications (0)
Data not yet available