Clinical trial NCT00620100 (phase 2, status: terminated)
Conditions: breast neoplasms
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    the study was early terminated due to lack of recruitment.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Female patient with histologically or cytologically documented breast adenocarcinoma

          2. First local or metastatic relapse

          3. Patients must have received a prior neoadjuvant or adjuvant Taxotere®-based
             chemotherapy regimen, provided this chemotherapy was completed > than or = to 12
             months prior to enrollment date

          4. Prior hormone or immune therapy is allowed. Antitumoral adjuvant hormone therapy may
             be continued during the study period, provided it was started > 12 months prior to
             study enrollment

          5. Her2/neu negative tumor demonstrated by immunohistochemistry (IHC 0 or 1+) or by
             fluorescence in situ hybridation (FISH -). A patient with tumor assessed as 2+ by IHC
             can be enrolled if the tumor is negative by FISH.

          6. ECOG performance status of 0 to 2

          7. Normal cardiac function confirmed by LVEF or shortening fraction (MUGA scan or
             echocardiography, respectively, within normal limits for the institution) assessed
             within 3 months prior to study entry. An ECG must be obtained within 4 weeks prior
             study entry and must demonstrate no clinically significant abnormality.

          8. Patients are required to have at least one measurable lesion according to RECIST
             guidelines

          9. Adequate organ function defined by:

               1. Hematology: Neutrophils > than or = to 2.0 109/L, Platelets > than or = to 100
                  109/L, Hemoglobin > than or = to 10 g/dL

               2. Hepatic function: Total bilirubin within normal limits, AST (SGOT) and ALT (SGPT)
                  < than or = to 1.5 UNL, alkaline phosphatase < than or = to 2.5 UNL (unless
                  accompanied by extensive bone metastases)

         10. Negative pregnancy test (urine or serum) within 7 days prior to registration for all
             women of childbearing potential

         11. Written informed consent prior to beginning specific protocol procedures must be
             obtained and documented according to the local regulatory requirements

        Exclusion Criteria

          1. Prior therapy for advanced or recurrent disease

          2. Previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²

          3. Previous radiation therapy having involved more than 25% of bone marrow; incomplete
             recovery from toxicity of radiation therapy

          4. Symptomatic brain metastases and clinically diagnosed leptomeningeal metastases

          5. Isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis
             (i.e., unmeasurable disease according to the RECIST guidelines)

          6. Pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade 2
             according to NCI-CTC AE criteria version 3.0

          7. Pregnant or lactating women or women of childbearing potential not using adequate
             contraception

          8. Other serious illness or medical conditions, including:

               1. Congestive heart failure or unstable angina pectoris, previous history of
                  myocardial infarction within 1 year from study entry, uncontrolled hypertension
                  or high-risk uncontrolled arrhythmias

               2. History of significant neurologic or psychiatric disorders including psychotic
                  disorders, dementia or seizures that would hamper understanding and giving
                  informed consent.

               3. Active uncontrolled infection

               4. Active peptic ulcer, uncontrolled diabetes mellitus

          9. Past or current history of neoplasm other than breast carcinoma, except:

               1. Curatively treated non-melanoma skin cancer.

               2. in situ carcinoma of the cervix.

               3. Other cancer curatively treated and with no evidence of disease for at least 10
                  years

         10. Chronic treatment with corticosteroids unless initiated > 6 months prior to study
             entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)

         11. Definite contraindications for the use of corticosteroids

         12. Likelihood of requiring treatment during the study period with drugs not permitted by
             the clinical study protocol (see Section 6.2)

         13. Concurrent treatment with other investigational drugs. Active treatment as part of
             another clinical therapeutic trial within 30 days prior to study entry

         14. Concurrent treatment with any other anti-cancer therapy, except adjuvant hormone
             therapy started > than or = to 12 months prior to study enrollment. Bisphosphonates
             for management of bone metastases or osteoporosis/osteopenia are allowed

         15. History of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80),
             epirubicin or doxorubicin

         16. Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study

         17. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to
             return for follow-up visits, and unlikelihood of completing the study

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.