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

You may not participate in this study if:

1	Concurrent neoadjuvant treatment with chemotherapy, endocrine therapy, or radiotherapy
2	Known hypersensitivity to azacytidine or mannitol
3	Pre-existing hepatic impairment or renal impairment
4	Intent to receive additional neoadjuvant therapy prior to surgery
5	Concurrent use of an HDAC inhibitor or hydralazine
6	Known diagnosis of HIV infection
7	Major surgery <4 weeks prior to starting study drug
8	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
9	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
10	Prior anti-estrogens (SERM or aromatase inhibitors) within 6 months of study entry
11	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 clinical.trials@med.usc.edu.

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