Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer MedDRA version: 16.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Avastin 25 mg/ml concentrate for solution for infusion.
Product Name: Bevacizumab
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Halaven 0.44 mg.ml solution for in
Sponsors
Consorzio Oncotech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Female patients =18 years of age. 3. Histologically confirmed HER2-negative adenocarcinoma of the breast with documented progression of disease per investigator assessment following or during first-line treatment with Bevacizumab in combination with Paclitaxel for MBC; patients can have measurable or non-measurable disease; 4. A minimum of 4 cycles of Bevacizumab 15 mg/kg or 6 cycles 10 mg/kg received in the first-line setting. 5. Patients must have received Bevacizumab in combination with Paclitaxel. 6. ECOG performance status (PS) of 0-2. 7. At least 28 days since prior radiation therapy or surgery and recovery from treatment. 8. Patients must have measurable disease which must be evaluable per RECIST v1.1. 9. Estimated life expectancy of =12 weeks 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 61 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 61
Exclusion criteria
Exclusion criteria: 1. Patients who have received anti-angiogenic therapy other than Bevacizumab for the first-line treatment of MBC. 2. Patients who have exclusively received endocrine treatment in combination with Bevacizumab until the first progression. 3. Positive or unknown HER2/neu status or for whom determination of HER2 status is not possible. 4. Current, recent (within 4 weeks or 2 half-lives, whichever is greater, before day 1) or planned participation in an experimental drug study - other than a Bevacizumab breast cancer study. 5. Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix or breast within the last 5 years. 6. Any laboratory values at baseline as follows: Hematology: - ANC 1.5 except for patients on stable anticoagulant therapy - aPTT =1.5 times ULN or greater than the lower limit of the therapeutic range Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of Day 1, Cycle 1. Serum chemistry: - Total bilirubin >1.5 volte ULN - AST or ALT >2 volte ULN (>5 times ULN for patients with known liver involvement) - ALP >2 times ULN (>5 times ULN for patients with known liver involvement and >7 times ULN for patients with known bone involvement). 7. Inadequate renal function, defined as: a. Creatinine clearance <50 mL/min b. Urine dipstick for proteinuria =2+ unless a 24-hour protein =1 g is demonstrated. 8. Psychiatric or addictive disorders 9. Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry. 10. Patients who are treated with any medicinal product that contraindicates the use of any of the study drugs, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications. 11. Bevacizumab-specific exclusions 12. Eribulina-specific exlusions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of Eribulin in combination with Bevacizumab for second-line treatment of human epidermal growth factor receptor 2–negative metastatic breast cancer progressing after first-line therapy with Bevacizumab and Paclitaxel;Secondary Objective: Other assessments of the efficacy and safety of Eribulin in combination with Bevacizumab;Primary end point(s): Overall response rate (ORR) based on BOR;Timepoint(s) of evaluation of this end point: Until approximately 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical Benefit Rate (CBR) - Second Line Progression Free Survival (PFS) - Overall survival (OS) - 1 year OS - Safety and tolerability - Duration of response - Quality of Life (QoL) ;Timepoint(s) of evaluation of this end point: Until approximately 30 months | — |
Countries
Italy
Contacts
Public ContactGiovanni Cucchiara
Clinical Research Technology
Outcome results
None listed