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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292083
Recruitment Status : Withdrawn (No accrual last 2 years)
First Posted : February 9, 2011
Last Update Posted : February 6, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
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 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 Not Applicable

Detailed Description:
PRIMARY OBJECTIVES: I. To evaluate the ability of deoxyribonucleic acid (DNA) methylation inhibition using 5-azacitidine to induce expression of the estrogen receptor (ER) and progesterone receptor (PR) genes in solid human triple negative invasive breast cancer. SECONDARY OBJECTIVES: I. To determine the effect of systemic 5-azacitidine therapy on the expression of other methylated genes in triple negative invasive breast cancer using an Illumina GoldenGate array. OUTLINE: Patients receive azacitidine intravenously (IV) over 10-40 minutes 5 days a week for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo definitive breast surgery within 12 days of the last dose of azacitidine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial to Evaluate the Biological Activity of 5-azacitidine on ER and PR Expression in Triple Negative Invasive Breast Cancer
Study Start Date : January 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: Treatment
See Detailed Description
Drug: azacitidine
Given IV
Other Names:
  • 5-AC
  • 5-azacytidine
  • azacytidine
  • Vidaza

Other: laboratory biomarker analysis
Correlative studies

Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry

Genetic: polymerase chain reaction
Correlative studies
Other Name: PCR

Genetic: western blotting
Correlative studies
Other Names:
  • Blotting, Western
  • Western Blot

Genetic: nucleic acid sequencing
Correlative studies
Other Names:
  • Gene Sequencing
  • Molecular Biology, Nucleic Acid Sequencing

Procedure: therapeutic conventional surgery
Undergo definitive breast surgery

Primary Outcome Measures :
  1. Percent of participants with ER/PR response after receiving 10 doses of 5-Azacitidine [ Time Frame: 6 months after enrollment of last patient ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292083

Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
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Principal Investigator: Agustin Garcia, MD University of Southern California

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Responsible Party: University of Southern California Identifier: NCT01292083     History of Changes
Other Study ID Numbers: 1B-09-15
NCI-2011-00117 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors