Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer

Exclusion Criteria

• •Pregnant or lactating women
• •Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
• •Clinically significant cardiovascular disease, requiring medication during the study and which might interfere with regularity of the study treatment, or not controlled by medication.
• •Radiation of the target lesion within the last 4 weeks prior to randomization
• •Prior radiation to ≥ 30% of bone marrow
• •Active bacterial, viral or fungal infection
• •Known HCV infection
• •Patients with clinically apparent brain metastases or evidence of a spinal cord compression
• •Major surgery within 14 days before enrollment
• •Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
• •Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
• •Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
• •History of other malignancy; patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
• •Prior treatment with a platinum derivative (except in (neo-)adjuvant setting if breast cancer recurrence did not occur within 12 months after (neo-)adjuvant chemotherapy completion) and/or with a proteasome inhibitor
• •Known hypersensitivity to the study drugs