Metastatic Breast Cancer
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: docetaxel
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Liisa Elomaa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed breast cancer • Metastatic disease confirmed by x-ray/ CT/ US/ bone scan, biopsy is optional • Female > 18 years of age • ECOG performance status under or equal to 2 • If patient has received taxanes as adjuvant therapy, a minimum of 6 months has passed since the end of taxane treatment prior randomization · Patient has not received taxanes for metastatic disease. Other chemotherapy for metastatic disease is allowed. • Prior hormonal treatment regimens are allowed • At least one measurable lesion by CT/MRI/US. if only bone metastases present, at least one of them have to be lytic. • Adequate hematology: - neutrophils > 1.5 x 109/l - platelets > 100 x 109/l - Hb > 100 g/l (after transfusion when needed) • Adequate renal function: serum creatinine under or equal to 1.25 x upper normal limit • Adequate liver function - bilirubin under or equal to upper normal limit (except if liver metastasis present, 1.25 x UNL allowed) - ASAT/ALAT under or equal to 1.5 x upper normal limit - alkaline phosphatase under or ewual to 5 x upper normal limit; patients with bone metastases who have alkaline phosphatase over or equal to 5 x upper normal limit are allowed to participate if they have normal liver function and no hepatic lesions) • Consent form signed and dated before randomisation • Able to comply with the scheduled follow-up and with the management of toxicities 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: • Patients with pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study but should be monitored closely for any deterioration. • Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, uncontrolled hypertension, ischemic heart disease, congestive heart failure, pulmonary embolism or myocardial infarction within previous 12 months, unstable diabetes or other reason preventing use of corticosteroids, autoimmune disease. • History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin • Pregnant or lactating women (or potentially fertile women not using adequate contraception)• Peripheral neuropathy = grade 2, unless related to mechanical etiology • Concurrent use of corticosteroids unless chronic treatment (i.e. initiated > 6 months prior to study entry) at low doses (under or equal to 20 mg methylprednisolone or equivalent) • History of allergic reaction to docetaxel or other drugs containing the excipient TWEEN 80®. • Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy • Patients who cannot be regularly followed up for psychological, social, family or geographic reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of two docetaxel dosing schedules: Taxotere 50mg/m2 every 2 weeks vs. Taxotere 100mg/m2 every 3 weeks Primary endpoint: to compare time to treatment failure (TTF) in the two treatment arms. ;Secondary Objective: Secondary endpoint: to compare the toxicity profile and response rate according to WHO criteria in the two treatment arms;Primary end point(s): To compare the safety and efficacy of two docetaxel dosing schedules: Taxotere 50mg/m2 every 2 weeks vs. Taxotere 100mg/m2 every 3 weeks | — |
Countries
Finland
Outcome results
None listed