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

Korábbi kezelés

• 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).
• 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
• 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
• Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment

Laborértékek

• 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.

• Written informed consent obtained prior to any study-specific procedure
• Female or male age ≥ 18 years
• Able to comply with the protocol
• Histologically or cytologically confirmed, HER2 (human epidermal growth factor 2) -negative, men or women with breast adenocarcinoma
• WHO performance status ≤ 2
• Adequate hematological function Absolute neutrophil count (ANC) ≥1.0 x 109/L AND Platelet count ≥100 x 109/L AND Hemoglobin ≥ 10 g/dL (may be transfused to maintain or exceed this level)
• Adequate liver function Total bilirubin \<1.5 x upper limit of normal (ULN) AND AST (aspartate aminotransferase), ALT (alanine aminotransferase) \<2.5 x ULN (in cohort I); AST, ALT \<5 x ULN (in cohort II)
• Adequate renal function Serum creatinine ≤1.25 x ULN (and if measured: Creatinine clearance within normal reference values)
• Women should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months and premenopausal levels of FSH (follicle stimulating hormone), LH (luteinizing hormone) and oestradiol) must have a negative serum pregnancy test within 28 days prior to inclusion into the study.