breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: Velcade
Pharmaceutical Form: Powder for solution for injection
Other descriptive name: BORTEZOMIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3,5-
Sponsors
AZ St Augustinus, Wilrijk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Female adult (> 18 years) patients with metastatic breast cancer, 2) Postmenopausal status defined as either a. > 55 years b. bilateral ovariectomy c. 3.0x109/L, ANC > 1.5x109/L, PLTs> 100x109/L, Hb >10gr/dL, 11) Normal liver function defined by a bilirubin 6 months, 13) One line of chemotherapy for metastatic disease is allowed provided this was not the last treatment received prior to study entry, 14) No peripheral neuropathy > grade 1, 15) No other life-threatening disease, 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) Non-measurable disease as sole disease sites as defined by RECIST, 2) More than one line of chemotherapy for metastatic disease, 3) Prior radiotherapy within two weeks prior to study entry, 4) Surgery within two weeks prior to study entry, 5) Other invasive cancer diagnosis within 5 years prior to study entry, 6) Severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, 7) Uncontrolled diabetes mellitus, (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug, 8) Pregnant or breast feeding, 9) Neuropathy > or = grade II, 10) Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used 11) Serious medical or psychiatric conditions that precludes participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate whether the addition of bortezomib to a SERM or AI will show clinical activity in patients with documented progressive disease while being treated with the identical endocrine agent. Clinical activity is defined by clinical benefit which consists of these patients obtaining at least either stable disease, partial or complete response according to RECIST criteria, for at least 8 weeks, since the start of Velcade (41). This should occur in at least 2 patients in the first 14 evaluable patients from both either treatment group A or B (see below) which equals to a clinical benefit of > 7%.;Secondary Objective: to define the activity of the NF-kappa B initiated pathway in tumors of patients whose disease progresses and thus experiencing clinically defined (RECIST) endocrine resistance, -to elucidate the changes in the ER and NF-kappaB pathway in the patients after treatment with bortezomib, if possible in tumor tissue. ;Primary end point(s): The primary endpoint is that in this group of 28 patients, 14 in each group, at least 7% of patients should obtain clinical benefit (SD+PR+CR). If we are unable to demonstrate that the clinical benefit rate is at least 7%, this regimen should not be considered for further testing. | — |
Countries
Belgium
Outcome results
None listed