University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 1B-09-15


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

Type: Treatment
Phase: Pilot
Status: Not Open (Closed)
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Agustin Garcia, M.D.
Other Trial Staff:  Kristy Watkins, R.N., Nancy Perez, R.N., Margarita Carranza, D.M., America Casillas-Lopez, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Histologically 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.
2Resectable tumor measuring 2 cm or more
3Females, age 18 or older
4SWOG performance status of < / = 1
5AGC = / >1.5; platelets = / >100,000; Hgb = / >9.0
6SGOT and SGPT < / = 2.5 x uln (< / = 5.0 x uln if with liver mets)
7Creatinine < / = 2.0 or calculated creatinine clearance = / > 50 ml/min
8Albumin = / > 3.0; K = / > LLN; P = / > LLN; Ca = / > LLN; Mg > LLN
9Accessible for treatment and follow-up
10Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Concurrent neoadjuvant treatment with chemotherapy, endocrine therapy, or radiotherapy
2Known hypersensitivity to azacytidine or mannitol
3Pre-existing hepatic impairment or renal impairment
4Intent to receive additional neoadjuvant therapy prior to surgery
5Concurrent use of an HDAC inhibitor or hydralazine
6Known diagnosis of HIV infection
7Major surgery <4 weeks prior to starting study drug
8Pregnant 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
9Other 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
10Prior anti-estrogens (SERM or aromatase inhibitors) within 6 months of study entry
11Underlying 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 clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.