Phase II Study of Dasatinib BMS-354825 for Advanced Triple-negative Breast Cancer - ND

• Conditions: Recurrent or progressive locally-advanced or metastatic triple-negative breast cancer.; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2006-002045-36-IT
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

Signed written informed consent according to institutional guidelines. Invasive breast cancer based on previous biopsy, documented as negative for expression of Estrogen and Progesterone Receptor 10 of cells stained and for Her2/neu IHC 0-1 or CISH/FISH-negative A paraffin-embedded tissue block from prior surgery must be available Measurable, recurrent or progressive, locally-advanced or metastatic disease assessed within 28 days prior to study drug start. At least one target lesion must be identified. Prior chemotherapy with an anthracycline, a taxane, or both adjuvant or metastatic Zero or one chemotherapy regimen in the locally-advanced or metastatic setting Recovered to Grade 61486;1 from toxicities of prior therapy except alopecia Performance status ECOG 0 1 Adequate organ function CTCAE v.3.0 severity grading Hepatic enzymes AST, ALT , Total bilirubin all Grade 0 1 Serum Ca2 61486; 61472;Lower Limit of Normal LLN Serum K , Mg2 , Phosphate all Grade 0 1 Creatinine Grade 0 2 Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0 1 Females, age 61486; 61472;18 years Women of childbearing potential WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization hysterectomy, bilateral tubal ligation or bilateral oophorectomy or is not postmenopausal defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy HRT with documented serum follicle stimulating hormone FSH level 35mIU/mL . Even women who are using oral implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermicides to prevent pregnancy or practicing abstinence or where partner is sterile e.g., vasectomy , should be considered to be of child bearing potential. WOCBP must have a negative serum or urine pregnancy test minimum sensitivity 25 IU/L or equivalent units of HCG within 72 hours prior to start of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study. Women who are pregnant or breastfeeding Women with a positive pregnancy test on enrollment or prior to study drug administration Metastatic disease confined to bone only Symptomatic CNS metastasis see section 7.2.1 Any anti-neoplastic therapy, including radiotherapy, or intravenous bisphosphonate within 14 days prior to study drug start Prior administration of any small-molecule targeted kinase inhibitor or any investigational agent i.e. defined as an agent not approved in any cancer indication Other malignancy requiring radiotherapy or systemic treatment within 3 years Concurrent medical condition which may increase the risk of toxicity, including Pleural or pericardial effusion of any grade Clinically-significant coagulation or platelet function disorder e.g. known von Willebrand s disease Infection requiring intravenous antibiotics Requirement for prohibited concomitant therapy see section 6.4.1 Ongoing or recent 61486;3 months significant gastrointestinal bleeding Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc 450 msec. Fridericia correction , EF 40 or major conduction abnormality unless a cardiac pacemaker is present Other medical condition which in the opinion of the Investigator might confer an unacceptable increase in risk

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified