Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT01695057
Eligibility Criteria:
Inclusion Criteria:
* Resectable tumor measuring 2cm or more
* Histologically documented, newly diagnosed, 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 human epidermal growth factor receptor 2 (HER2)/neu by fluorescent in situ hybridization (FISH) using institutional standard; 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/uL
* 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 of 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 anti-cancer treatment with chemotherapy, endocrine therapy, biologically targeted therapy or radiotherapy
* Known hypersensitivity to SAHA
* Preexisting 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 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01695057
Study Brief:
Protocol Section:
NCT01695057