A Phase II Controlled Study of pegylated liposomal Doxorubicin (PLD, CAELYX) and Carboplatin for the Preoperative Treatment of Advanced Breast Cancer - Cola
- Conditions
- A PLD and Carboplatin based neoadjuvant treatment regimen with less cardiotoxicity (as compared to other anthracyclines) and generally reduced side effects is of interest not only for breast cancer patients at cardiac risk but also elderly patients and patients not willing to accept alopecia
- Registration Number
- EUCTR2007-004925-64-DE
- Lead Sponsor
- HSK Research GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 46
•Histological confirmed breast cancer (pT1c and larger, non-inflammtory, M0)
•Steroid receptor status negative or low receptor-positive values (IRS <6, or only one receptor positive)
•Negative Her2 receptor
•One-dimensionally measurable disease. To be considered measurable, a baseline lesion must have a minimum diameter to compensate for measurement error:
>1 cm by ultrasound or mammography or mamma-MR
•Age greater than or equal to 18 years
•ECOG performance status less than or equal to 2.
•Laboratory values (performed within 14 days prior to study drug administration, inclusive).
-Absolute neutrophil count (ANC) ³ 1500/mm3
-Platelet count ³ 100,000/mm3
-Hemoglobin ³ 10g/dl or ³100 g/l
-Urea and serum creatinine < 1.5 times upper limit of laboratory normal.
-Total bilirubin and liver enzymes must be in hospital laboratory normal range
•Adequate renal function: the glomerular filtration rate (GFR) will be estimated from serum creatinine according to the method of Jelliffe or Cockroft-Gault Calculated creatinine clearance = 30 mL/minute .
•A baseline assessment of LVEF by 2-D echocardiogram within six weeks of registration is required. Patients must have an LVEF = 50%.
•Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
•A life expectancy of greater than 12 weeks
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
•The study population does not include those subjects with tumor size smaller than pT1c in diameter.
•Documented history of heart failure or current heart failure(New York Heart Association Class II or greater, or clinical evidence of congestive heart failure), cardiomyopathy or current arrhythmia (atrial fibrillation or flutter or ventricular arrhythmia, except for occasional unifocal premature ventricular contractions), or an episode of myocardial infarction within the past 6 months
•Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics. Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamousa cell carcinoma of the skin
•Evidence of primary malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater.
Women of childbearing potential who are not using an effective no hormonal method of contraception. Women of childbearing potential must have a negative pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
•Pregnant or nursing women.
•Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior entering this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method