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Sponsor: Borstkanker Onderzoek Groep
Conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
Interventions: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine, Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
Countries: Netherlands
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Female patients ≥ 18 years old. * Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy. * Patients with measurable or evaluable-only (RECIST 1.1) * Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status. * HER2/neu-negative disease * Patients with an ECOG Performance Status ≤ 2. * Life expectancy of \> 12 weeks. * Signature of Informed Consent Form Exclusion Criteria: * Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer. * Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment. * Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment. * Prior radiotherapy covering more than 30% of marrow-bearing bone. * Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to study treatment. * Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy. * Chronic daily treatment with aspirin * Chronic daily treatment with corticosteroids, with the exception of inhaled steroids. * Current or recent treatment with another investigational drug or participation in another investigational study. * Inadequate bone marrow, liver, renal function * INR \> 1.5 or an aPTT \> 1.5 x ULN within 7 days prior to first study treatment. * Known CNS disease, except for treated brain metastases. * Patients with concurrent active malignancy * Pregnant or lactating * Women of childbearing potential not using effective, non-hormonal means of contraception * Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment * Core biopsy or other minor surgical procedure, within 7 days prior to day 1. * Significant vascular disease within 6 months prior to day 1. * Any previous venous thrombo-embolism \> CTC Grade 3. * History of haemoptysis * History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. * Uncontrolled hypertension * Clinically significant (i.e. active) cardiovasculair disease * LVEF by MUGA or ECHO \< 50%. * History of abdominal fistula, Grade 4 bowel obstruction or GI perforation, intra-abdominal abscess within 6 months of randomization. * Serious non-healing wound, peptic ulcer or bone fracture. * Known hypersensitivity to any of the study drugs or excipients. * Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. * Psychiatric illness, physical examination or laboratory findings that may interfer with protocol
- Amsterdam, Netherlands