Clinical trial NCT01288261 (phase 1, status: completed)
Conditions: human epidermal growth factor 2 negative carcinoma of breast, male breast cancer, recurrent breast cancer, stage iiic breast cancer, stage iv breast cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.621, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: paclitaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent has been obtained

          -  Life expectancy of at least 3 months

          -  Histologically or cytologically confirmed, Her-2 negative breast cancer with evidence
             of metastatic disease

          -  Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors
             (RECIST)

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status =< 2

          -  Adequate hematologic function (absolute neutrophil count [ANC] >= 1,500 cells/uL;
             hemoglobin >= 9 g/dL; platelets >= 100,000/uL and =< 500,000/uL)

          -  Adequate renal function (serum creatinine =< 1.5 mg/dL or calculated creatinine
             clearance >= 60 ml/min)

          -  Adequate hepatic function (total or direct bilirubin =< Upper Limit of Normal (ULN),
             Alk Phos =< 4 x ULN)

          -  Prothrombin time international normalized ratio within institutional normal limits

          -  Activated partial thromboplastin time =< 1.5 x ULN

          -  New York Heart Association classification I or II

          -  Female patients must have a negative urine pregnancy test at prestudy (not applicable
             to patients with bilateral oophorectomy and/or hysterectomy or to those patients who
             are postmenopausal)

        Exclusion Criteria:

          -  Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease,
             Hemophilia)

          -  Any current evidence of clinically significant active bleeding

          -  Any history of significant thromboembolic events (i.e., deep vein thrombosis or
             pulmonary thromboembolism) within the last five years or requirement for ongoing
             therapy with oral or parenteral anticoagulants; central venous catheter-related
             thrombosis > 12 months ago and low dose anticoagulants to maintain patency of lines
             are allowed; patients taking anticoagulants (e.g., prophylactic heparin or enoxaparin)
             are required to observe the washout period of 1 week prior to study drug infusion on
             Study Day 1

          -  Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement,
             anti-estrogen); patients taking concurrent hormone therapy are required to observe the
             washout period of 2 weeks prior to study drug infusion on Study Day 1

          -  Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in
             distal extremities)

          -  More than one prior chemotherapy regimen for metastatic disease (prior adjuvant
             chemotherapy or any number of prior hormonal therapies are allowed)

          -  Chemotherapy, immunotherapy or radiotherapy within 2 weeks of Study Day 1 or not
             having recovered from significant treatment-related side effects due to agents
             administered previously; patients who have receive nitrosoureas and mitomycin C
             therapy are required to observe the washout period of 6 weeks prior to study drug
             infusion on Study Day 1

          -  Allergy to polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g.
             cyclosporine)

          -  Symptomatic or clinically active Central Nervous System (CNS) disease

          -  Major surgery within 4 weeks of Study Day 1

          -  Female patients pregnant or nursing

          -  All patients of reproductive potential must agree to use appropriate non-hormonal form
             of contraception

          -  Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)

          -  Any history of angina pectoris, coronary artery disease or cerebrovascular accident,
             or transient ischemic attack

          -  A history of any condition requiring anti-platelet therapy (e.g., phosphodiesterase
             inhibitors, adenosine diphosphate receptor antagonists) with the exception of general
             cardiovascular prophylaxis with aspirin

          -  Cardiac arrhythmia requiring medical therapy

          -  Serious non-healing wound (including wound healing by secondary intention, ulcer, or
             bone fracture)

          -  Requirement for chronic daily steroid use

          -  Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus
             (HBV), or Hepatitis C Virus (HCV)