Clinical trial NCT01624441 (phase 1, status: completed)
Conditions: estrogen receptor negative, her2/neu negative, male breast carcinoma, progesterone receptor negative, recurrent breast carcinoma, stage iv breast cancer ajcc v6 and v7, triple-negative breast carcinoma
ICD codes: Z17.1, A41.50, A41.59, E70.320, Z17.1, Z67.11, Z67.21, Z67.31, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, Z17.0, Z17.1, T47.0X6S, T50.7X6S, T47.0X3S, T47.0X4S, T47.0X5S, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: dinaciclib, epirubicin hydrochloride
SMILES: CCC1=C2N=C(C=C(NCC3=CC=C[N+]([O-])=C3)N2N=C1)N1CCCC[C@H]1CCO, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed estrogen receptor (ER)/progesterone
             receptor (PR)/human epidermal growth factor receptor 2 (HER2) negative carcinoma of
             the breast that is metastatic or unresectable and for which standard curative or
             palliative measures do not exist or are no longer effective; for purposes of this
             study, triple negative disease will be tumors that have ER/PR < 10% and HER2 =< 1+ by
             immunohistochemistry (IHC) or HER2 fluorescent in situ hybridization (FISH)
             non-amplified (ratio < 2)

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Patients must have no more than two prior chemotherapy regimens for metastatic breast
             cancer; in patients who develop disease recurrence within 6 months of adjuvant or
             neoadjuvant chemotherapy, the adjuvant or neoadjuvant therapy will be considered one
             prior regimen for metastatic disease

          -  Life expectancy of greater than 3 months

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal limits unless clinical diagnosis of Gilbert's syndrome

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Patients must be disease free of prior malignancy for >= 5 years with the exception of
             curatively treated squamous cell carcinomas of the skin or carcinoma in situ of the
             cervix or breast

          -  Must have at least one site of objective measurable or evaluable disease; baseline
             measurements and evaluations must be obtained within 4 weeks of start of therapy

          -  Patients must have no history of prior therapy with dinaciclib

          -  Concurrent use of hormonal therapy is not permitted; concurrent radiation therapy is
             not permitted; bisphosphonates are allowed, provided that they were started no less
             than two weeks prior to initiating protocol therapy

          -  Patients must have completed and recovered from the effects of prior chemotherapy (<
             grade 2 toxicity) excluding alopecia

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (barrier method of birth control; abstinence) prior to study entry and for the
             duration of study participation; should a woman become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, she should inform
             her treating physician immediately; men treated or enrolled on this protocol must also
             agree to use adequate contraception prior to the study, for the duration of study
             participation, and 4 months after completion of dinaciclib administration

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events

          -  Patients who are receiving any other investigational agents

          -  Patients with untreated brain metastases should be excluded from this clinical trial

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition as epirubicin or dinaciclib

          -  Patients receiving any medications or substances that are inhibitors or inducers of
             cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) are ineligible

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with dinaciclib

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible

          -  Patients who have had prior organ allograft or require immunosuppressive therapy

          -  Patients who have received a cumulative dose of doxorubicin of greater than 360 mg/m^2
             or epirubicin of greater than 600 mg/m^2; patients who have received > 240 mg/m^2 of
             doxorubicin or > 400 mg/m^2 of epirubicin should be advised to undergo evaluation of
             left ventricular ejection fraction (LVEF) with echocardiogram or multi gated
             acquisition scan (MUGA) prior to initiating therapy

          -  Patients with a history of New York Heart Association class 3 or 4 heart failure, or
             history of myocardial infarction, unstable angina or cerebral vascular accident (CVA)
             within 6 months of protocol registration

          -  LVEF < 50% by MUGA or echocardiogram (ECHO)

          -  Patients who have history of PR prolongation or atrioventricular (AV) block