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
Conditions
Interventions
Trade Name: Caelyx 2mg/ml / Vial 10ml
Product Name: Caelyx
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin hydrochloride in pegylated liposomal formulaton
C
Sponsors
HSK Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histological confirmed breast cancer (pT1c and larger, non-inflammtory, M0) •Steroid receptor status negative or low receptor-positive values (IRS 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Complete Response (CR):Disappearance of all target lesions to determine the proportion of subjects who have a clinical complete or partial response in patients with primary breast cancer ;Secondary Objective: the proportion of subjects who have a pathological complete or partial response Frequency of breast conserving surgery Time to progression: the interval between the date of study entry and the date of disease progression. Overall survival: the interval between the date of study entry and the subject’s death from any cause progression or death due to disease progression. Time to treatment failure: the interval from the date of first study drug administration to the date of discontinuation of treatment ;Primary end point(s): The primary efficacy endpoint will evaluate overall response rates (complete plus partial responses) after 6 cycles of therapy | — |
Countries
Germany
Outcome results
None listed