Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting

Exclusion Criteria

• •1. Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).
• •2. Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma, in situ cervix cancer or breast cancer
• •3. Clinically significant (i.e. active) cardiovascular disease for example cardiovascular accident (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA (New York Heart Association) Class ≥II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
• •4. Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment
• •5. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.