Patients with Locally Recurrent or Metastatic Breast Cancer MedDRA version: 9.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Interventions
Product Name: SORAFENIB
Pharmaceutical Form: Coated tablet
Other descriptive name: SORAFENIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical for
Sponsors
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the breast. 2. Measurable or evaluable locally recurrent or metastatic disease. (Locally recurrent disease must not be amenable to resection with curative intent.) All scans used to document measurable or evaluable disease must be done within 4 weeks prior to randomization. 3. Age >= 18 years. Women who are ER+ or PgR+ and candidates for endocrine therapy, must be post-menopausal as defined below: Bilateral oophorectomy; or No menses for at least 12 months in patients with an intact uterus, not on gonadatropin suppressing agents; or Follicle-stimulating hormone (FSH) in postmenopausal range in patients = 9.0 g/dl Absolute neutrophil count (ANC) >= 1,500/UL Platelet count >= 100,000/UL Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER2) [gene amplification by fluorescence in situ hybridization (FISH) or 3+ over-expression by immunohistochemistry (IHC)]. Patients with unknown HER-2 status are not eligible. 2. Patients with active brain metastases. Patients with neurological symptoms must undergo a contrast CT scan or MRI of the brain to exclude active brain metastasis. Patients with treated brain metastases are eligible provided they have no evidence of disease and are off definitive therapy (including steroids) at least 3 months prior to randomization. 3. Prior chemotherapy or endocrine therapy for locally recurrent or metastatic breast cancer. 4. Patients with unknown hormone receptor status. 5. Patients who are ER+ or PgR+ and are pre-menopausal and unwilling to undergo pharmacological ovarian ablation 6. Women who are pregnant or breast-feeding. 7. Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization. 8. Evidence or history of bleeding diathesis or coagulopathy. 9. Serious, non-healing wound, ulcer, or bone fracture. 10. Substance abuse or medical, psychological, or social condition that may interfere with the patient?s participation in the study or evaluation of the study results. 11. Pre-existing peripheral neuropathy >= Grade 2. 12. Use of cytochrome P450 enzyme-inducing anti-epileptic drugs (such as phenytoin, carbamazepine, or phenobarbital) is not allowed. 13. Cardiac disease: Congestive heart failure >class II New York Heart Association (NYHA) (See Appendix B), or Unstable angina (anginal symptoms at rest), or new-onset angina (began within the last 3 months), or myocardial infarction within the 6 months prior to randomization, or Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. 14. Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic pressure >90 mm Hg) despite optimal medical management. 15. Thrombolic, embolic, venous, or arterial events, such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. 16. Pulmonary hemorrhage/bleeding event >National Cancer Institute (NCI-CTCAE) Grade 2 within 4 weeks of first dose of study drug. 17. Any other hemorrhage/bleeding event >= NCI-CTCAE Grade 3 within 4 weeks of randomization. 18. Active clinically serious infection >NCI-CTCAE Grade 2. 19. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. 20. Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis], or any cancer curatively treated >5 years prior to randomization. 21. Known or suspected allergy to sorafenib, letrozole or hypersensitivity to docetaxel or drugs using the vehicles polysorbate 80 or ethanol. 22. Prior or concurrent use of St. John?s Wort or rifampin (rifampicin) within 3 weeks of randomization. 23. Prior or concurrent treatment with any agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors (VEGFR) (licensed or investigational). 24. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression-free survival (PFS) in patients treated with sorafenib and standard first-line therapy versus patients treated with placebo and standard first-line therapy for locally recurrent or metastatic breast cancer.;Secondary Objective: To compare the objective response rate (ORR), duration of response, time to progression (TTP), and overall survival of patients treated with sorafenib and standard first-line therapy versus patients treated with placebo and standard first-line therapy. To compare the safety of patients treated with sorafenib and standard first-line therapy versus patients treated with placebo and standard first-line therapy.;Primary end point(s): Progression-free survival from the date of starting treatment. | — |
Countries
Germany, Italy
Outcome results
None listed