Clinical trial NCT00499122 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, docetaxel, doxorubicin, nov 002
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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, N[C@@H](CCC(=O)N[C@@H](CSSC[C@H](NC(=O)CC[C@H](N)C(O)=O)C(=O)NCC(O)=O)C(=O)NCC(O)=O)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Females age 18 years or older.

          -  The ability to provide written informed consent prior to study specific screening
             procedures, with the understanding that the patient has the right to withdraw from the
             study at any time.

          -  Histologically confirmed infiltrating (invasive) breast cancer by core needle biopsy,
             with no evidence of metastatic disease except to the ipsilateral axillary lymph nodes.

          -  Clinical stage IIB - IIIC (T2-4, N0 or N1, M0 or - any T, N1-3, M0) breast cancer. The
             primary tumor must be greater than or equal to 2 cm (T2-4) or with pathologically
             proven axillary nodal involvement (N1-3).

          -  Patients with inflammatory breast cancer (T4) are permitted into the study.

          -  Clinically palpable tumor that meets the criteria of RECIST for palpable measurable
             disease. The primary tumor must be greater than or equal to 2 cm (T2-4) or with
             pathologically proven axillary nodal involvement (N1-3). Bilateral synchronic breast
             cancers are allowed but one of the primary tumors should be selected as the target
             tumor.

          -  Primary tumor may be estrogen or progesterone receptor negative or positive, and human
             epidermal growth factor receptor 2 (HER-2/neu) negative as determined by either
             Fluorescent In Situ Hybridization (FISH) or 0-2+ staining by immunohistochemistry
             (IHC) (Hercept™).

          -  Normal cardiac ejection fraction (EF ≥ 50%) as determined by screening multigated
             acquisition scan (MUGA) or echocardiogram.

          -  No prior history of myocardial infarction, congestive heart failure, symptomatic
             coronary artery disease, or cardiac arrhythmias.

          -  Patients must be ambulatory with Eastern Cooperative Oncology Group (ECOG) Performance
             Status of 0-1.

          -  The patient or her caregiver must be able to self administer daily subcutaneous
             injections.

          -  Life expectancy greater than 6 months.

        Exclusion Criteria:

          -  Prior therapy of any modality for the treatment of breast cancer

          -  Any prior therapy with an anthracycline or a taxane for any other indication

          -  HER-2 positive breast cancer defined as either gene amplification by Fluorescent In
             Situ Hybridization (FISH) or 3+ staining by IHC (Hercept™).

          -  Women who have a positive pregnancy test, no pregnancy test available, who are
             pregnant or who are lactating.

          -  Women of childbearing potential must agree to use a reliable and appropriate
             contraceptive method, which could include a double barrier method (condom plus
             diaphragm), an intrauterine device or oral contraceptives. Women with ER or PR
             positive breast cancer, should not, however, use oral contraceptives as a method of
             contraception. Postmenopausal women must have been amenorrheic for at least 12 months
             to be considered of non-childbearing potential.

          -  Women with breast cancer that do not have palpable breast tumors at screening.

          -  History of another malignancy within the last 5 years except curatively treated basal
             cell carcinoma of the skin or cervical intraepithelial neoplasia.

          -  Clinically significant (i.e. active) cardiac disease (NYHA Grade II or greater
             congestive heart failure, symptomatic coronary artery disease, unstable angina, and
             cardiac arrhythmia not well-controlled with medication), myocardial infarction within
             the last 6 months prior to study start, or screening ejection fraction of < 50%.

          -  Any of the following abnormal laboratory values:

               -  Absolute neutrophil count < 1.5 x 109/L

               -  Platelet count < 100 x 109/L

               -  Serum bilirubin > 1.5 x upper limit of normal (ULN)

               -  Serum alanine transaminase (ALT), aspartate transaminase (AST) > 2.5 x ULN

               -  Serum creatinine > 2.0 mg/dL or 177mmol/L or calculated creatinine clearance by
                  the method of Cockcroft and Gault < 50mL/min).

          -  Any severe or poorly controlled systemic disease (e.g., hypertension; clinically
             significant cardiovascular, pulmonary, or metabolic disease, disorders of
             wound-healing, ulcer or bone fracture).

          -  Patients who have received any investigational treatment within 4 weeks of study
             start.

          -  Known infection with HIV, Hepatitis B virus (HBV), or Hepatitis C virus (HCV).

          -  Known hypersensitivity to any of the components of NOV-002 or to any of the study
             drugs.

          -  Patients assessed by the investigator to be unable or unwilling to comply with the
             requirements of the protocol.