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A Pilot Clinical Trial to Evaluate the Biological Activity of 5-azacitidine on ER and PR Expression in Triple Negative Invasive Breast Cancer

18 Years
Not Enrolling
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

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Trial Information

A Pilot Clinical Trial to Evaluate the Biological Activity of 5-azacitidine on ER and PR Expression in Triple Negative Invasive Breast Cancer

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months after enrollment of last patient

Safety Issue:


Principal Investigator

Agustin Garcia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

March 2013

Related Keywords:

  • 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
  • Breast Neoplasms