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A Pilot Study of Eribulin in Breast Cancer (BC) Patients With Brain Metastases Previously Treated With Anthracyclines and Taxanes

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ClinicalTrials.gov Identifier: NCT03412955
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Wong Siew Wei, Tan Tock Seng Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Eribulin Mesylate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Eribulin in Breast Cancer (BC) Patients With Brain Metastases Previously Treated With Anthracyclines and Taxanes
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Eribulin
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.
Drug: Eribulin Mesylate
1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Duration of Response in Brain [ Time Frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles ]
    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. .

  3. Assessment of toxicities such as neuropathy, hematological and hepatological toxicities [ Time Frame: 3 years ]

    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.




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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients with histologically or cytologically confirmed carcinoma of the breast.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Patients with known estrogen and/or progesterone receptor-expressing tumors may have additionally been treated with hormonal therapy
  7. Resolution of all previous chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤Grade 2 and alopecia
  8. Age above 21 years
  9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  10. Life expectancy of more than 3 months
  11. 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
  12. 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.
  13. 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
  14. Patient's willing and able to comply with the study protocol for the duration of the study
  15. 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

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Severe/uncontrolled intercurrent illness/infection.
  4. 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)
  5. Patients with known positive HIV status
  6. 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
  7. Patients with neuropathy > Grade 2 at screening.
  8. Patients with QTC > 500 msec at screening.
  9. 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.
  10. Patient with leptomeningeal only disease, without other measurable brain metastasis, is excluded.

Information from the National Library of Medicine

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): NCT03412955


Contacts
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Contact: Elaine Tabanguil +6568802216 Elaine_E_TABANGUIL@ttsh.com.sg
Contact: Xiaoying Xu Xiaoying_XU@ttsh.com.sg

Locations
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Singapore
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
Contact: Elaine Tabanguil    +6568802216    Elaine_E_TABANGUIL@ttsh.com.sg   
Taiwan
Chang-Gung Memorial Hospital Recruiting
Taoyuan city, Taiwan, 333
Contact: Wen-Chi Shen    +88633281200 ext 2517    c220273@cgmh.org.tw   
Sponsors and Collaborators
Tan Tock Seng Hospital

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Responsible Party: Wong Siew Wei, Principal Investigator, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT03412955     History of Changes
Other Study ID Numbers: JS16104
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Taxane
Antineoplastic Agents