Brain MetastasisPhase 2CRANIALNCT01913067
Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC
A Phase 2 study testing Cabazitaxel and Contrast-enhanced whole brain MRI in people with Brain Metastasis and Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC). OBJECTIVES: Primary: The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis, Breast Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Cabazitaxel and Contrast-enhanced whole brain MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age>18, ECOG 0-1
- Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
- In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
- In patients with breast cancer, known estrogen and progesterone receptor status.
- Evidence of measurable disease in the brain (at least 1cm)
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- Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.
- No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE) score ≥ 25/30.
- No more than 4 prior lines of systemic chemotherapy in the metastatic setting
- Adequate hematopoietic function defined as:
- Hemoglobin ≥ 9.0g/dL
- Absolute neutrophilic count ≥ 1.5 x 109L
- Platelet count ≥ 100 x 109L
- Adequate hepatic function defined as:
- AST ≤ 2.5 x upper limit of normal (ULN)
- ALT ≤ 2.5 x ULN
- Total bilirubin ≤ 1.0 x ULN
- Adequate renal function defined as serum creatinine ≤ 1.5 x ULN. If creatinine ranges from 1.0 - 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance >60 mL/min are eligible
- Adequate contraceptive method in patients with child-bearing potential.
Who cannot join
- History of prior whole brain irradiation
- Progressive neurological symptoms requiring immediate brain irradiation
- Pregnancy or lactation
- History of hypersensitivity reaction to taxanes
- History of hypersensitivity to polysorbate 80 containing agents
- Current or planned treatment with strong inhibitors or inducers of cytochrome P450.
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- Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or immunotherapy
- Leptomeningeal carcinomatosis
- Contra-indication to contrast-enhanced MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer
A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC).
OBJECTIVES:
Read more
Primary:
The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation.
Secondary:
- To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery
- To determine the effect of cabazitaxel on the time to developing neurological symptoms
- To determine the effect of cabazitaxel on the time to disease progression in the brain
- To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts
- To determine the safety of cabazitaxel
Read the detailed description
This is a single arm, prospective trial using a 2-stage Simon design, in which eligible patients will receive intravenous cabazitaxel for two cycles followed by response evaluation. Based on the pre-specified criteria of response (intra-cranial, patient will be allowed to continue on study drug.
- Conditions
- Brain Metastasis, Breast Cancer, Non Small Cell Lung Cancer
- Being tested
- Cabazitaxel, Contrast-enhanced whole brain MRI
- Keywords
- brain metastasis, breast cancer, HER2 negative, NSCLC
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtana
Intravenous, 25 mg/m2 every 3 weeks
Contrast-enhanced whole brain MRIProcedure or surgery
Evaluation of the volumetric reduction in the size of the brain lesion(s).
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Eligible patients will receive intravenous 25mg/m2 cabazitaxel every 3 weeks. Contrast-enhanced whole brain MRI will be performed every two cycles. Patients who show ≥50% volumetric reduction in the size of the brain lesion(s) will continue on cabazitaxel until disease progression or unacceptable toxicity. Patients who show evidence of disease progression and/or developed progressive neurological symptoms will be taken off study and offered whole brain irradiation. Patients who do not meet both criteria can have the choice either to continue on study drug or to be taken off study according to the investigator discretion. Receives: Drug: Cabazitaxel; Procedure: Contrast-enhanced whole brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of brain lesions.
Objective response defined as a >= 50% volumetric reduction of brain lesions in the absence of increasing steroid use and progressive neurologic symptoms.
Measured: week 6
Secondary outcomes (5)
Time to whole brain irradiation or radiosurgery
Determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery
Measured: every 6 weeks until disease progression.
Time to developing neurological symptoms.
Determine the effect of cabazitaxel on the time to developing neurological symptoms
Measured: every 6 weeks until disease progression.
Time to progression in the brain
Determine the effect of cabazitaxel on the time to disease progression in the brain.
Measured: every 6 weeks until disease progression.
Time to progression extra-cranial
Determine the effect of cabazitaxel on the time to disease progression outside the brain
Measured: every 6 weeks until disease progression.
Toxicity
Determine the safety of cabazitaxel
Measured: every 3 weeks until 30 days after last treatment administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Scientific rationale is deemed obsolete. Funders lost interest in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Ahmad Awada, MD, PhD, Principal investigator, Institute Jules Bordet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913067
- Sponsor's protocol ID
- CE2100
- Other IDs
- 2012-005194-32
- Acronym
- CRANIAL
- Status last verified
- Jul 2014
- First submitted
- 18 Jul 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01913067
- Acronym / sponsor ID
- CRANIAL / CE2100
- Conditions
- Brain Metastasis, Breast Cancer, Non Small Cell Lung Cancer
- Keywords
- brain metastasis, breast cancer, HER2 negative, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Scientific rationale is deemed obsolete. Funders lost interest in the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Sep 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 31 Jul 2013 (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.
A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC).
OBJECTIVES:
Primary:
The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation.
Secondary:
- To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery
- To determine the effect of cabazitaxel on the time to developing neurological symptoms
- To determine the effect of cabazitaxel on the time to disease progression in the brain
- To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts
- To determine the safety of cabazitaxel
Detailed description
This is a single arm, prospective trial using a 2-stage Simon design, in which eligible patients will receive intravenous cabazitaxel for two cycles followed by response evaluation. Based on the pre-specified criteria of response (intra-cranial, patient will be allowed to continue on study drug.
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: Cabazitaxel, Procedure: Contrast-enhanced whole brain MRIEligible patients will receive intravenous 25mg/m2 cabazitaxel every 3 weeks. Contrast-enhanced whole brain MRI will be performed every two cycles. Patients who show ≥50% volumetric reduction in the size of the brain lesion(s) will continue on cabazitaxel until disease progression or unacceptable toxicity. Patients who show evidence of disease progression and/or developed progressive neurological symptoms will be taken off study and offered whole brain irradiation. Patients who do not meet both criteria can have the choice either to continue on study drug or to be taken off study according to the investigator discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent
- Age>18, ECOG 0-1
- Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
- In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
- In patients with breast cancer, known estrogen and progesterone receptor status.
Key exclusion criteria (9 listed)
- History of prior whole brain irradiation
- Progressive neurological symptoms requiring immediate brain irradiation
- Pregnancy or lactation
- History of hypersensitivity reaction to taxanes
- History of hypersensitivity to polysorbate 80 containing agents
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: JevtanaIntravenous, 25 mg/m2 every 3 weeks | Drug | Cabazitaxel |
| Contrast-enhanced whole brain MRIEvaluation of the volumetric reduction in the size of the brain lesion(s). | Procedure or surgery | Cabazitaxel |
Primary outcome
Reduction of brain lesions.
Time frame: week 6
Objective response defined as a >= 50% volumetric reduction of brain lesions in the absence of increasing steroid use and progressive neurologic symptoms.
5 secondary outcomes
Time to whole brain irradiation or radiosurgery
Time frame: every 6 weeks until disease progression.
Time to developing neurological symptoms.
Time frame: every 6 weeks until disease progression.
Time to progression in the brain
Time frame: every 6 weeks until disease progression.
Time to progression extra-cranial
Time frame: every 6 weeks until disease progression.
Toxicity
Time frame: every 3 weeks until 30 days after last treatment administration.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
Ahmad Awada, MD, PhD principal investigator
Institute Jules Bordet
1 site 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 and Contrast-enhanced whole brain MRI in people with Brain Metastasis and Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 19 inclusion and 9 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: withdrawn, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction of brain lesions. (time frame: week 6). 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 24 Jul 2014.