Azacitidine in Treating Patients With Triple Negative Stage I-IV Invasive Breast Cancer That Can Be Removed By Surgery

NCT01292083 | Withdrawn DMC

• 2 other identifiers: 1B-09-15NCI-2011-00117
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percent of participants with ER/PR response after receiving 10 doses of 5-Azacitidine

  6 months after enrollment of last patient

Study Arms (1)

Treatment

EXPERIMENTAL

See Detailed Description

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

Interventions

azacitidine DRUG

Given IV

Also known as: 5-AC, 5-azacytidine, azacytidine, Vidaza

Treatment

laboratory biomarker analysis OTHER

Correlative studies

Treatment

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Treatment

polymerase chain reaction GENETIC

Correlative studies

Also known as: PCR

Treatment

western blotting GENETIC

Correlative studies

Also known as: Blotting, Western, Western Blot

Treatment

nucleic acid sequencing GENETIC

Correlative studies

Also known as: Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing

Treatment

therapeutic conventional surgery PROCEDURE

Undergo definitive breast surgery

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Azacitidine; Immunohistochemistry; Polymerase Chain Reaction; Blotting, Western; Base Sequence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Nucleic Acid Amplification Techniques; Genetic Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Molecular Probe Techniques; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Agustin Garcia, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 9, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 6, 2014

Record last verified: 2014-02