Breast CancerPhase 2NCT01693549
Study of Cabazitaxel in Patients With Metastatic Breast Cancer Previously Treated With Taxanes
A Phase 2 study testing Cabazitaxel in people with Breast Cancer, run by Hellenic Cooperative Oncology Group at 17 sites in Greece.
Trial summary
The purpose of this study is to determine whether cabazitaxel is effective in the treatment of metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 17 sitesGreece
- Study dates
- Sep 2012to 20 Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Greece17 sites
Dept of Medical Oncology, 251 General Air Force Hospital
Athens, 11525
2nd Dept of Medical Oncology, General Hospital of Athens "Hippokratio"
Athens, 11527
Oncology section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"
Athens, 11528
Division of Oncology, 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"
Athens, 12462
2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, 14564
3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, 14564
3rd Dept of Medical Oncology, Hygeia Hospital
Athens, 15123
1st Dept of Medical Oncology, Metropolitan Hospital
Athens, 18547
2nd Dept of Medical Oncology, Metropolitan Hospital
Athens, 18547
2nd Dept of Medical Oncology, Agios Savvas Cancer Hospital
Athens
Oncology Dept., General Hospital of Chania "Agios Georgios"
Chania, 73300
Dept of Medical Oncology, University Hospital of Heraklion
Heraklio, 71110
Dept of Medical Oncology, Ioannina University Hospital
Ioannina, 45110
General Hospital of Patra "Agios Andreas"
Pátrai, 26335
Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
Rio, Patras, 26504
Dept of Medical Oncology, Papageorgiou General Hospital
Thessaloniki, 56429
Dept of Medical Oncology, Thermi Clinic S.A
Thessaloniki, 57001
About this study
Official title: Phase II Study of Cabazitaxel as 2nd Line Treatment in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Taxanes
The purpose of this study is to determine whether cabazitaxel is effective in the treatment of metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Cabazitaxel
- Keywords
- HER-2 negative, Metastatic breast adenocarcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtana, XRP6258
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | 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. Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR).
Measured: At an average of 24 months for each patient
Secondary outcomes (5)
Duration of response.
Measured: 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)
Measured: 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)
Measured: Defined as the time in months from study entry until the time of death, assessed up to 30 months.
Assessment of safety and tolerability.
Distribution of adverse events according to severity grade.
Measured: 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
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.
Measured: Tumor blocks and blood DNA will be collected at study entry and plasma at study entry, on week 3 and week 6 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion10 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Angelos Koutras, MD, Study chair, Division of Oncology,Dept of Internal Medicine,University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693549
- Sponsor's protocol ID
- HE 11B/11
- Other IDs
- 2011-003625-97
- Status last verified
- Jul 2017
- First submitted
- 20 Sep 2012
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cabazitaxel as 2nd Line Treatment in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Taxanes
- ClinicalTrials.gov ID
- NCT01693549
- Acronym / sponsor ID
- HE 11B/11
- Conditions
- Breast Cancer
- Keywords
- HER-2 negative, Metastatic breast adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Sep 2012
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cabazitaxel is effective in the treatment of metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CabazitaxelCabazitaxel(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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabazitaxelAlso: Jevtana, XRP6258 | Drug | Cabazitaxel |
Primary outcome
Objective response rate (ORR).
Time frame: At an average of 24 months for each patient
5 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelos Koutras, MD study chair
Division of Oncology,Dept of Internal Medicine,University Hospital of Patras
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Breast Cancer, run by Hellenic Cooperative Oncology Group at 17 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR). (time frame: At an average of 24 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.