Advanced breast cancer (ABC)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Female patients aged 18 years or older 3. Females with histological/cytological confirmation of breast cancer 4. Patients fulfilling one of the following criteria: a) At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST); b) Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease (as defined by RECIST). 5. Patients should have immunohistochemistry confirmed receptor negative breast cancer or patients who have failed hormonal treatment and who are only eligible for cytotoxic therapy 6. Patients who have failed either on or within 1 year of adjuvant therapy (excluding taxanes), or who have progressed on first line therapy for advanced disease (excluding taxanes) 7. WHO performance status (PS) 0 to2 and life expectancy >12 weeks. Patients with PS 3 will be eligible unless the Investigator believes the poor PS is predominantly due to co-existing morbidity (e.g. severe cardiac impairment) 8. Negative pregnancy test for women of child-bearing potential 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
Exclusion criteria: 1. Treatment within 4 weeks before randomisation and/or whilst on study, treatment with the following: Non-approved or experimental drug; Chemotherapy, radiotherapy or other anticancer therapy 2. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) 3. Previous enrolment or randomisation of treatment in the present study 4. Previous definitive radiotherapy (e.g. to chest wall) within 6 weeks before randomisation 5. Any unresolved toxicity > Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy 6. History of hypersensitivity to active or inactive excipients of ZD6474, placebo or docetaxel 7. Major surgery within 4 weeks of randomisation, or incompletely healed surgical incision 8. Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix). 9. Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 1 week 10. Any of the following laboratory values: Serum bilirubin greater than the upper limit of reference range (ULRR); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 x ULRR or alkaline phosphatase greater than 2.5 ULRR; Serum creatinine >1.5 x ULRR or creatinine clearance or =2) within 3 months before entry, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia 14. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, symptomatic or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded. 15. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age 16. Previous QT prolongation with other medication that required discontinuation of that medication 17. Presence of left bundle branch block 18. QTc with Bazett’s correction unmeasurable or > or =480msec or greater on screening ECG (Note: if patient has QTc interval >or =480msec on screening ECG, the screen ECG may be repeated twice, at least 24 hours apart. The average QTc from the 3 screening ECGs must be 160 mmHg or diastolic blood pressure >110 mmHg) 22. Currently rec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety and tolerability of ZD6474 in combination with docetaxel in the treatment of ABC by review of adverse events and laboratory parameters.;Primary end point(s): The primary outcome variable is a progression event defined as the earliest of: · Objective disease progression at the data cut-off date (approximately 6 months after the last patient is randomised), as measured using RECIST criteria · Death from any cause ;Main Objective: To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology. | — |
Countries
Hungary, Spain, Sweden
Outcome results
None listed