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

This study has been withdrawn prior to enrollment.
(No accrual last 2 years)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01292083
First received: February 2, 2011
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Azacitidine
U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • Percent of participants with ER/PR response after receiving 10 doses of 5-Azacitidine [ Time Frame: 6 months after enrollment of last patient ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292083

Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Agustin Garcia, MD USC/Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01292083     History of Changes
Other Study ID Numbers: 1B-09-15, NCI-2011-00117
Study First Received: February 2, 2011
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Azacitidine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013