HER-2 negative metastatic breast cancer MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent •Female patients aged 18 to 75 years •Patients must have received 1st-line chemotherapy for locally recurrent / metastatic disease •Prior taxane-containing treatment (paclitaxel, docetaxel or nab-paclitaxel), either for advanced disease or as neoadjuvant / adjuvant chemotherapy. In case of early relapse (relapse during neoadjuvant / adjuvant chemotherapy or disease-free interval less than 6 months), neoadjuvant / adjuvant chemotherapy will be considered as 1st-line treatment •Diagnosis of HER-2 negative (HER-2 =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: •Patients that have received more than one lines of chemotherapy for locally recurrent / metastatic disease •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a wash-out period of two weeks is necessary for patients who are already on these treatments) (Appendix A and B) •Patients with CTC grade 2 or greater neuropathy at baseline •Diagnosis of spinal cord compression or carcinomatous meningitis •Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) •Patients with clinically significant cardiac disease (e.g. congestive heart failure, unstable angina, myocardial infarction) within 6 months from study entry •Any other significant acute or chronic medical or psychiatric condition or abnormal laboratory finding which, according to the investigator’s opinion, could result in excessive danger, regarding the participation of the patient in the study. •Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocol •Any concurrent active malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix •Concurrent administration of other investigational treatments and/or anti-neoplastic agents •Pregnancy or lactation. Patients should be surgically sterile or post-menopausal or they must agree to use adequate contraceptive methods during study period. For all patients of childbearing potential a serum or urine pregnancy test is needed. The definition of effective contraceptive methods will be based on the investigator’s opinion. •History of severe hypersensitivity reaction (=grade 3) to docetaxel or polysorbate 80 containing drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the clinical activity of cabazitaxel regarding the objective response rate (ORR).;Secondary Objective: •To assess the activity of cabazitaxel regarding the duration of response, progression-free survival (PFS) and overall survival (OS). •To assess the safety profile of cabazitaxel concerning hematological and non-hematological toxicities. Translational research objectives •To evaluate potential predictive biomarkers for response to study treatment. •To investigate the association of genetic polymorphisms in drug-metabolizing enzymes and drug transporters with the toxicity and efficacy of cabazitaxel. ;Primary end point(s): To determine the objective response rate (ORR);Timepoint(s) of evaluation of this end point: Imaging assessment to determine response to treatment will be performed after 8, 16, 24 weeks and every 3 months thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the duration of response 2. Evaluation of progression-free survival (PFS) 3. Evaluation of overall survival (OS) 4. Assessment of safety and tolerability of cabazitaxel 5. To evaluate potential correlation of biomarkers with study treatment the association of genetic polymorphisms with the toxicity and efficacy of study treatment. ;Timepoint(s) of evaluation of this end point: 1.Defined as the period measured in months from the time that measurement criteria are first met for partial response or complete response (whichever is recorded first) until the first date of documented progressive disease or death from any cause without prior documentation of progression. 2.Defined as the time in months from study entry until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. 3.Defined as the time in months from study entry until the time of death. 4.Evaluation of Adverse Events (AEs) will be performed every 21 days (per cycle) during treatment 5. At study entry, on week 6 and on week 8 of treatment | — |
Countries
Greece
Contacts
Public ContactClinical Trials
Hellenic Cooperative Oncology Group
Outcome results
None listed