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A Pilot Clinical Trial to Evaluate the Biological Activity of 5-azacytidine on ER and PR Expression in Triple Negative Invasive Breast Cancer.
Defintions of terms and FAQ about clinical trials.
Agustin Garcia, M.D.
Other Trial Staff:
Kristy Watkins, R.N., Nancy Perez, R.N., Margarita Carranza, D.M., America Casillas-Lopez, D.M.
to see study documents.
You may participate in this study if:
Histologically documented triple negative invasive breast cancer characterized by 0% IHC nuclear staining for ER-a, 0% IHC nuclear staining for PR-a, and no amplification of HER2/neu by FISH. Standard IHC assays for ER and PR use antibodies to ER-a and PR-a and PR-ß.
Resectable tumor measuring 2 cm or more
Females, age 18 or older
SWOG performance status of < / = 1
AGC = / >1.5; platelets = / >100,000; Hgb = / >9.0
SGOT and SGPT < / = 2.5 x uln (< / = 5.0 x uln if with liver mets)
Creatinine < / = 2.0 or calculated creatinine clearance = / > 50 ml/min
Albumin = / > 3.0; K = / > LLN; P = / > LLN; Ca = / > LLN; Mg > LLN
Accessible for treatment and follow-up
Signed an approved study-specific informed consent and HIPAA
You may not participate in this study if:
Concurrent neoadjuvant treatment with chemotherapy, endocrine therapy, or radiotherapy
Known hypersensitivity to azacytidine or mannitol
Pre-existing hepatic impairment or renal impairment
Intent to receive additional neoadjuvant therapy prior to surgery
Concurrent use of an HDAC inhibitor or hydralazine
Known diagnosis of 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. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment
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 anti-estrogens (SERM or aromatase inhibitors) within 6 months of study entry
Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.