Metastatic and/or recurrent cancer of the breast
Conditions
Interventions
Product Name: Tesmilifene
Product Code: DPPE/YMB-1002
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Tesmilifene
CAS Number: 92981-78-7
Current Sponsor code: DPPE/YMB-1002
Other descri
Sponsors
YM Biosciences Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological proof of breast cancer 2. Documented evidence of metastatic and/or recurrent breast cancer. Patients with locally advanced and inoperable lesions are also eligible 3. Imaging within 21 days prior randomization. Exceptions will be made only for patients who have had negative examinations within 35 days prior to randomization 4. Presence of at least one uni-dimensional measurable lesion. a. If the patient’s only lesion(s) have been irradiated, progression in the site(s) following radiotherapy must have occurred. b. Minimum indicator lesion size must be as follows: CT scan > 2 cm; Ultrasound > 2 cm; Chest x-ray > 1 cm; skin lesion or node > 1 cm 5. Previous therapy a. Anti-hormonal: if patients have had hormone-responsive disease, randomization is permitted after 6 weeks off anti-hormonal therapy unless there is evidence of progressive disease in which case patients will be randomized earlier. All hormonal therapy must be discontinued prior to randomization b. Chemotherapy: patients may have had one adjuvant chemotherapy regimen with the following restrictions: i. no previous exposure to anthracycline/anthracenedione-based chemotherapy (doxorubicin, epirubicin, or mitoxantrone), ii. if received non-anthracycline based adjuvant chemotherapy, it should completed a minimum of 4 weeks prior to randomization. iii. No previous chemotherapy for metastatic disease permitted. iv. Immunotherapy and experimental therapy should be stopped a minimum of 4 weeks prior to randomization c. Radiation: should be stopped a minimum of 4 weeks prior randomization, with the exemption of palliative radiotherapy 6. ECOG performance status 0, 1 or 2 7. Age > 16 years (the minimum age limit may be determined by the local center’s policies regarding the age at which an individual may sign their own informed consent) 8. Able to complete baseline and follow up Quality of Life questionnaires 9. Acceptable Hematology and Chemistry results 10. MUGA scan showing LVEF ? 50% (within 21 days of randomization) 11. Patient must sign an Inform Consent Form prior to randomization 12. Patient must be accessible for treatment and follow up at the same center as where randomized 13. Protocol treatment is to begin within 5 working days of randomization 14. Disease free interval (DFI) less than or equal to 36 months 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. Previous malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin or in situ cervical cancer or any other cancer treated more than five years prior to study entry (presumed cured). 2. Patients with brain or meningeal metastases 3. Patients whose only measurable disease is in bone 4. Patients with clinical evidence of congestive heart failure (CHF), recent myocardial infarction within 6 months, uncontrolled arterial hypertension, unstable angina, cardiomyopathy or atrial or ventricular arrhythmias even if medically controlled 5. Patients with any history of seizure disorder 6. Patients with other serious illnesses or medical conditions, including clinically significant or uncontrolled inflammation or infectious disease, which would not permit the patient to be managed according to the protocol. 7. Pregnant or breast-feeding females. All women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to randomization 8. Patients on COX 1 or 2 prostaglandin inhibitors (e.g. ASA, Celebrex) must comply with guidelines within the protocol for concomitant therapy 9. Patients on H1 antagonists (e.g. antihistamines or antidepressants) that cannot be discontinued during their time on study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the combination of DPPE (tesmilifene), epirubicin and cyclophosphamide is superior to epirubicin and cyclophosphamide therapy alone in the of patients with metastatic and/or recurrent cancer of the breast as demonstrated by the primary endpoint of survival.;Secondary Objective: To determine whether the combination of DPPE, epirubicin and cyclophosphamide is superior to epirubicin and cyclophosphamide therapy alone in the treatment of metastatic breast cancer as demonstrated by the secondary endpoint of response rate, progression-free survival, quality of life and toxicity.;Primary end point(s): To determine whether the combination of DPPE, epirubicin and cyclophosphamide is superior to epirubicin and cyclophosphamide therapy alone in the treatment of patients with metastatic and/or recurrent cancer of the breast as demonstrated by the primary endpoint of survival. | — |
Countries
Estonia
Outcome results
None listed