Clinical Research Directory

Inclusion Criteria: * Age ≥ 18 years old * Histologically or cytologically confirmed adenocarcinoma of the breast * Locally recurrent or metastatic disease * HER 2 negative status * Requiring a first or a second-line chemotherapy for locally recurrent or metastatic disease. * Prior first line chemotherapy not containing Docetaxel * Measurable or evaluable disease according to RECIST 1.1 criteria * Allowed prior chemotherapy as follows : * Docetaxel in the neoadjuvant or adjuvant setting is allowed provided that relapse has been observed more than 12 months after the end of docetaxel treatment * Bevacizumab in 1st line is allowed with a wash-out of 4 weeks, with recovery to NCI-CTCAE v3.0 toxicity * ECOG performance status 0-1 * Adequate bone marrow, hepatic and renal functions as evidence by the following: * Hemoglobin ≥ 10 G/100 mL * Neutrophils count ≥ 1500 /mm3 * Platelets ≥ 100 000 /mm3 * Total bilirubin ≤ ULN (ULN:Upper Limit of Normal) * SGOT/SGPT ≤ 1.5 x ULN (≤ 2.5 x ULN in case of hepatic metastasis) * Serum alkaline phosphatase ≤ 2.5 x ULN * Creatinin clearance ≥ 45 ml/min or creatinin ≤ 1.5 x ULN * Proteinuria \< CTCAE grade 2 * Coagulation parameters: International normalised ratio (INR) ≤ 2, prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 50% of deviation of institutional ULN * Effective contraception for patients (male and female) with reproductive potential during their entire participation in the study and during 3 months after the last administration of Nintedanib or Docetaxel * Negative pregnancy test (serum beta-HCG) performed within 1 week prior to start of study treatment in females with reproductive potential * Patient covered by government health insurance * Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation Exclusion Criteria: * Concomitant hormone therapy for metastatic breast cancer * Patients with dysphagia, or inability to swallow the tablets * Other serious illness or medical conditions: Cardiac disease * Unstable diabetes * Uncontrolled hypercalcemia * Pregnancy or breast feeding woman * Unable for medical follow-up (geographic, social or mental reasons) * Prior treatment with Nintedanib or any other VEGFR inhibitor * Known hypersensitivity to the trial drugs , to their excipients, to peanut, to soya or to contrast media * Contra indication to the use of the backbone treatment and to the comparator * Active brain metastases (e.g. stable for \<4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation) * Leptomeningeal disease * Radiographic evidence of cavitary or necrotic tumors * Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels * History of clinically significant haemorrhagic or thromboembolic event in the past 6 months * Known inherited predisposition to bleeding or thrombosis * Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure \> NYHA II, serious cardiac arrhythmia, pericardial effusion) * Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix * Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy * Active or chronic hepatitis C and/or B infection * Active alcohol or drug abuse * Significant weight loss (\> 10% of BW) within past 6 months prior to inclusion into the trial