Study of Cabazitaxel in Patients With Metastatic Breast Cancer Previously Treated With Taxanes
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|ClinicalTrials.gov Identifier: NCT01693549|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Cabazitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cabazitaxel as 2nd Line Treatment in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Taxanes|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||July 10, 2017|
|Actual Study Completion Date :||July 20, 2017|
Cabazitaxel(XRP6258) will be administered on day 1 of each cycle, every 21 days, at a dose of 25 mg/m² by i.v. route in 1 hour. Treatment can be continued until patient's consent withdrawal, intolerable toxicity or documented disease progression.
- Objective response rate (ORR). [ Time Frame: At an average of 24 months for each patient ]
- Duration of response. [ Time Frame: From the time measurement criteria are first met for partial or complete response until the first date of documented progressive disease or death from any cause without prior documentation of progression assessed up to 30 months. ]
- Evaluation of progression-free survival (PFS) [ Time Frame: From study entry until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression, assessed up to 30 months. ]
- Evaluation of overall survival (OS) [ Time Frame: Defined as the time in months from study entry until the time of death, assessed up to 30 months. ]
- Assessment of safety and tolerability. [ Time Frame: Evaluation of Adverse Events will be performed every 21 days (per cycle) during treatment assessed up to 30 months. ]Distribution of adverse events according to severity grade.
- Value of prognostic and/or predictive biomarkers measured in tissue and blood samples [ Time Frame: Tumor blocks and blood DNA will be collected at study entry and plasma at study entry, on week 3 and week 6 of treatment. ]
βΙ,βΙΙ,βΙΙΙ,βIVb, βV-tubulin isotypes,HIF1α,microtubule-associated proteins such as Tau,MAP2,MAP4 & microtubule-sequestering proteins such as stathmin, will be assessed. Moreover, evaluation of p53,BCL2,BIM,γ-actin,LIMK2, TGFBI,Aurora-A,as well as the expression of the enzyme CYP3A and multidrug transporters such as P-glycoprotein. The abovementioned factors will be assessed by immunohistochemistry at the protein level and by quantitative real-time PCR at the RNA level.
Also, given the clinical significance of the anti-angiogenic effects of cytotoxic chemotherapy,we will investigate the effect of treatment on surrogate biomarkers of angiogenesis, such as VEGF-A as well as the effect of chemotherapy on kinetics of soluble biomarkers,using ELISA.
In addition,genetic polymorphisms in drug-metabolizing enzymes and drug transporters, such as the CYP3A and ABCB1 genes, will be explored in blood DNA and their association with the toxicity and efficacy of cabazitaxel will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693549
|Study Chair:||Angelos Koutras, MD||Division of Oncology,Dept of Internal Medicine,University Hospital of Patras|