Breast CancerPhase 2NCT03412955
A Pilot Study of Eribulin in Breast Cancer (BC) Patients With Brain Metastases Previously Treated With Anthracyclines and Taxanes
A Phase 2 study testing Eribulin Mesylate in people with Breast Cancer, run by Tan Tock Seng Hospital at 2 sites in 2 countries.
Trial summary
This is a pilot study, the principal investigator plans to enroll 14 patients. If 2 or more responses are documented, the principal investigator will consider to start a new phase II study. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Eribulin Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Mar 2017to 30 Apr 2020
- 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 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histologically or cytologically confirmed carcinoma of the breast.
- Patients with locally advanced or metastatic disease who have received an anthracycline (e.g. doxorubicin, epirubicin) and a taxane (e.g. paclitaxel, docetaxel), either in combination or in separate regimens. It can be used in neo-adjuvant, adjuvant or metastatic setting.
- Patients must have measurable brain metastases (minimum size of 10mm in long axis) which is asymptomatic and does not required any treatment or had failed to respond or progress after either radiation treatment or stereotactic radiosurgery.
- Patients who are deemed to have asymptomatic brain metastases should not be on systemic corticosteroid at enrolment. Patients who have brain metastases that have failed previous radiation therapy or stereotactic radiosurgery are allowed to be on systemic corticosteroid at enrolment. Baseline dose of corticosteroid should be documented.
- Patients with known HER2 positive tumors may additionally have been treated with trastuzumab and/or pertuzumab or trastuzumab emtasine in centers where this treatment is available.
- Patients with known estrogen and/or progesterone receptor-expressing tumors may have additionally been treated with hormonal therapy
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- Resolution of all previous chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤Grade 2 and alopecia
- Age above 21 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Life expectancy of more than 3 months
- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL or calculated creatinine clearance > 50 mL/minute (min) per the Cockcroft and Gault formula
- Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) above 1.5 x 109/L, hemoglobin above 10.0 g/dL, and platelet count above 100 x 109/L.
- Adequate liver function as evidenced by bilirubin less than 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) less than 3 x ULN (in the case of liver metastases less than 5 x ULN), or in case of bone metastases, liver specific alkaline phosphatase less than 3 x ULN
- Patient's willing and able to comply with the study protocol for the duration of the study
- Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice. However, hormonal therapy must be discontinued one week before administration of study
Who cannot join
- Patients who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
- Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (considered to be two methods of contraception, one of which must be a barrier method, e.g. condom, diaphragm or cervical cap). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Severe/uncontrolled intercurrent illness/infection.
- Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
- Patients with known positive HIV status
- Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated above 5 years previously with no subsequent evidence of recurrence
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- Patients with neuropathy > Grade 2 at screening.
- Patients with QTC > 500 msec at screening.
- Concurrent hormonal therapy for metastatic breast cancer is not allowed. However, Her2 positive metastatic breast cancer patients who progressed on prior anti-Her2 directed therapy may have concurrent eribulin and trastuzumab, but not trastuzumab emtasine.
- Patient with leptomeningeal only disease, without other measurable brain metastasis, is excluded.
Trial locations and contacts
2 sites in 2 countries.
Xiaoying Xu contact
2 sites in 2 countries
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Elaine Tabanguil, +6568802216, Elaine_E_TABANGUIL@ttsh.com.sg
Taiwan1 site, 1 recruiting
- Recruiting
Chang-Gung Memorial Hospital
Taoyuan City, 333
Wen-Chi Shen, +88633281200 ext. 2517, c220273@cgmh.org.tw
About this study
This is a pilot study, the principal investigator plans to enroll 14 patients. If 2 or more responses are documented, the principal investigator will consider to start a new phase II study. If there is less than 2 responses in the 14 patients, it is unlikely that Eribulin will produce 15% or more response rate in patients with active brain metastases, thus indicating no need to study further. Based on Poisson distribution, there is 38% probability of observing 1 or 0 response even if the underlying response is 15%. There is no null hypothesis, hence no p-value of significance.
- Conditions
- Breast Cancer
- Being tested
- Eribulin Mesylate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin MesylateDrug
1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin | Experimental | Patients enrolled into the study will receive Eribulin 1.4mg/m2 on days 1 and 8 of a 21-day treatment cycle till disease progression or non-tolerable toxicity. Receives: Drug: Eribulin Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response Rate in Brain as measured using RANO-BM criteria
To evaluate the tumor response rate in the the brain every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles.
Measured: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Secondary outcomes (3)
Extracranial objective tumor response rate as measured using RECIST 1.1 criteria
To evaluate the extracranial objective tumor response by doing CT Scan/MRI every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles.
Measured: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Duration of Response in Brain
To assess the duration of response by doing an MRI Brain every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles. .
Measured: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Assessment of toxicities such as neuropathy, hematological and hepatological toxicities
To assess the toxicities of patients receiving Eribulin. The assessment will include the physical examinations, weight and vital signs monitoring, 12 lead ECGs, 2D Echo, collection of Adverse Events (AE) as well as Laboratory assessments including hematology and chemistry.
Toxicity will be assessed based on the medical review of adverse events, reports and laboratory tests throughout the study.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start8 Mar 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Siew Wei, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412955
- Sponsor's protocol ID
- JS16104
- Status last verified
- Feb 2018
- First submitted
- 19 Dec 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Eribulin in Breast Cancer (BC) Patients With Brain Metastases Previously Treated With Anthracyclines and Taxanes
- ClinicalTrials.gov ID
- NCT03412955
- Acronym / sponsor ID
- JS16104
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 29 Jan 2018 (actual)
- 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.
This is a pilot study, the principal investigator plans to enroll 14 patients. If 2 or more responses are documented, the principal investigator will consider to start a new phase II study. If there is less than 2 responses in the 14 patients, it is unlikely that Eribulin will produce 15% or more response rate in patients with active brain metastases, thus indicating no need to study further. Based on Poisson distribution, there is 38% probability of observing 1 or 0 response even if the underlying response is 15%. There is no null hypothesis, hence no p-value of significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin | Experimental | Drug: Eribulin MesylatePatients enrolled into the study will receive Eribulin 1.4mg/m2 on days 1 and 8 of a 21-day treatment cycle till disease progression or non-tolerable toxicity. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients with histologically or cytologically confirmed carcinoma of the breast.
- Patients with locally advanced or metastatic disease who have received an anthracycline (e.g. doxorubicin, epirubicin) and a taxane (e.g. paclitaxel, docetaxel), either in combination or in separate regimens. It can be used in neo-adjuvant, adjuvant or metastatic setting.
- Patients must have measurable brain metastases (minimum size of 10mm in long axis) which is asymptomatic and does not required any treatment or had failed to respond or progress after either radiation treatment or stereotactic radiosurgery.
- Patients who are deemed to have asymptomatic brain metastases should not be on systemic corticosteroid at enrolment. Patients who have brain metastases that have failed previous radiation therapy or stereotactic radiosurgery are allowed to be on systemic corticosteroid at enrolment. Baseline dose of corticosteroid should be documented.
- Patients with known HER2 positive tumors may additionally have been treated with trastuzumab and/or pertuzumab or trastuzumab emtasine in centers where this treatment is available.
Key exclusion criteria (10 listed)
- Patients who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
- Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (considered to be two methods of contraception, one of which must be a barrier method, e.g. condom, diaphragm or cervical cap). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Severe/uncontrolled intercurrent illness/infection.
- Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
- Patients with known positive HIV status
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 |
|---|---|---|
| Eribulin Mesylate1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle. | Drug | Eribulin |
Primary outcome
Objective Tumor Response Rate in Brain as measured using RANO-BM criteria
Time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
To evaluate the tumor response rate in the the brain every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles.
3 secondary outcomes
Extracranial objective tumor response rate as measured using RECIST 1.1 criteria
Time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Duration of Response in Brain
Time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Assessment of toxicities such as neuropathy, hematological and hepatological toxicities
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Xiaoying Xu contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin Mesylate in people with Breast Cancer, run by Tan Tock Seng Hospital at 2 sites in 2 countries.
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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore, Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Tabanguil (+6568802216, Elaine_E_TABANGUIL@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Tumor Response Rate in Brain as measured using RANO-BM criteria (time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles). 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 27 Feb 2018.