- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693549
Study of Cabazitaxel in Patients With Metastatic Breast Cancer Previously Treated With Taxanes
Phase II Study of Cabazitaxel as 2nd Line Treatment in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Taxanes
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Athens, Greece, 11525
- Dept of Medical Oncology, 251 General Air Force Hospital
-
Athens, Greece, 11527
- 2nd Dept of Medical Oncology, General Hospital of Athens "Hippokratio"
-
Athens, Greece, 11528
- Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"
-
Athens, Greece, 12462
- Division of Oncology, 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"
-
Athens, Greece, 14564
- 2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
-
Athens, Greece, 14564
- 3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
-
Athens, Greece, 15123
- 3rd Dept of Medical Oncology, Hygeia Hospital
-
Athens, Greece, 18547
- 1st Dept of Medical Oncology, Metropolitan Hospital
-
Athens, Greece, 18547
- 2nd Dept of Medical Oncology, Metropolitan Hospital
-
Athens, Greece
- 2nd Dept of Medical Oncology, Agios Savvas Cancer Hospital
-
Chania, Greece, 73300
- Oncology Dept., General Hospital of Chania "Agios Georgios"
-
Heraklio, Greece, 71110
- Dept of Medical Oncology, University Hospital of Heraklion
-
Ioannina, Greece, 45110
- Dept of Medical Oncology, Ioannina University Hospital
-
Patra, Greece, 26335
- General Hospital of Patra "Agios Andreas"
-
Rio, Patras, Greece, 26504
- Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
-
Thessaloniki, Greece, 56429
- Dept of Medical Oncology, Papageorgiou General Hospital
-
Thessaloniki, Greece, 57001
- Dept of Medical Oncology, Thermi Clinic S.A
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 <2+ by immunohistochemistry and/or FISH or CISH negative) metastatic breast adenocarcinoma confirmed by the pathology department of the enrolling institution
- Eastern Cooperative Oncology Group performance status (PS) of 0-1
- Life expectancy of at least 12 weeks
- Measurable disease by the Response Criteria in Solid Tumors 1.1 (RECIST 1.1) method (at least one measurable lesion)
Laboratory values within the specified ranges within 1 week of study enrolment:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count of ≥ 1.5 x 10^9/L
- Thrombocyte count of ≥ 100 x 10^9/L
- Serum creatinine ≤ 1.5 upper limit of normal (ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded
- SGOT (AST), SGPT (ALT) ≤ 2.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN, total bilirubin ≤ ULN (the same limits also refer to patients with liver metastases)
- Previous treatment for loco-regional disease is allowed, including surgical procedures or palliative radiotherapy (such treatments must have been completed at least 4 weeks before enrolment)
- Compliance of the patient regarding scheduled visits, treatment plan, laboratory tests and other procedures of the study.
- The enrolment of patients with controlled brain metastases is allowed (metastases that have been treated with radiotherapy and remained stable for at least 4 weeks following the completion of radiation treatment)
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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cabazitaxel
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.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR).
Time Frame: At an average of 24 months for each patient
|
At an average of 24 months for each patient
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
Evaluation of Adverse Events will be performed every 21 days (per cycle) during treatment assessed up to 30 months.
|
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. |
Tumor blocks and blood DNA will be collected at study entry and plasma at study entry, on week 3 and week 6 of treatment.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Angelos Koutras, MD, Division of Oncology,Dept of Internal Medicine,University Hospital of Patras
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE 11B/11
- 2011-003625-97 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
Clinical Trials on Cabazitaxel
-
Jeffrey Yachnin M.D., PhD.SanofiCompletedMetastatic Castration Resistant Prostate CancerSweden
-
Krzysztof MisiukiewiczSanofi; Icahn School of Medicine at Mount SinaiCompleted
-
Vejle HospitalSanofiTerminated
-
Azienda Socio Sanitaria Territoriale degli Spedali...San Luigi Gonzaga HospitalUnknown
-
Institut für Klinische Krebsforschung IKF GmbH...Completed
-
Gustave Roussy, Cancer Campus, Grand ParisSanofiUnknownNon-seminomatous Germ-cell TumorsFrance
-
Rambam Health Care CampusCompleted
-
University Hospitals Bristol and Weston NHS Foundation...SanofiCompletedPenile NeoplasmUnited Kingdom
-
Brown UniversityTerminated
-
European Organisation for Research and Treatment...SanofiCompletedDedifferentiated LiposarcomaUnited Kingdom, Belgium, France, Italy