An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

• Register: ClinicalTrials.gov
• Last refreshed on: 1 June 2015
• Main ID: NCT01240421
• Date of registration: 01/10/2010
• Prospective Registration: Yes
• Primary sponsor: Eisai Inc.
• Public title: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
• Scientific title: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
• Date of first enrolment: March 2011
• Recruitment status: Approved for marketing
• URL: http://clinicaltrials.gov/show/NCT01240421
• Study type: Expanded Access
• Study design: N/A
• Phase: N/A

Countries of recruitment

Belgium, Canada, France, United Kingdom

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Patient's oncologist must have documented experience in a prior eribulin clinical
trial

- Recurrent, locally advanced or metastatic breast cancer that has progressed on or
after the last anti-cancer therapy

- Prior treatment with, ineligibility for, or commercial unavailability of each of the
following therapies:

1. Anthracyclines, taxanes, and capecitabine

2. Ixabepilone, in countries where this agent is marketed

3. Trastuzumab, for Her-2 positive disease

4. Hormonal therapy, in hormone receptor-positive disease

5. All other commercially available therapies, e.g. gemcitabine or vinorelbine,
used for the treatment of advanced breast cancer (see NCCN guidelines)

- ECOG performance status greater than or equal to 2

- Adequate kidney function: serum creatinine less than or equal to 2.0 mg/dL or
creatinine clearance greater than or equal to 40 mL/min

- Adequate bone marrow function: absolute neutrophil count greater than or equal to 1.5
x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth
factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L

- Adequate liver function: total bilirubin less than or equal to 1.5 x upper limit of
normal (ULN), alkaline phosphatase, alanine aminotransferase, and aspartate
aminotransferase less than or equal to 3 x ULN (or less than or equal to 5 x ULN in
case of liver metastases). If alkaline phosphatase is greater than 3 x ULN (in
absence of liver metastases) or greater than 5 x ULN (in presence of liver
metastases) AND patient also is known to have bone metastases, the liver specific
alkaline phosphatase must be used to assess liver function instead of total alkaline
phosphatase

- Willing and able to comply with all aspects of the treatment protocol

- Provision of written informed consent

- Female, aged at least 18 years

- Patients of childbearing potential must agree to be abstinent or to use a highly
effective method of contraception

Key Exclusion Criteria:

Eligibility for any other eribulin study open in the same region

- Existing anti-cancer therapy-related toxicities of grade 2 or more, except that
alopecia and grade 2 neuropathy are acceptable

- History of congestive heart failure with New York Heart Association Classification
greater than grade II, unstable angina, myocardial infarction within the past 6
months or serious cardiac arrhythmia

- Electrocardiogram with QTc interval of greater than or equal to 500 msec based upon
Bazett's formula (QTcB)

- The Investigator believes the patient to be medically unfit to receive eribulin or
unsuitable for any other reason

- Pregnancy (positive B-hCG test) or breastfeeding

- Hypersensitivity to eribulin or any of the excipients

- Brain or subdural metastases, unless local therapy has been completed and use of
corticosteroids for this indication has been discontinued for at least 4 weeks before
starting treatment in this protocol. Any signs (eg, radiologic) and/or symptoms of
brain metastases must be stable for at least 4 weeks before starting the treatment
protocol

- History of or concomitant medical condition that, in the opinion of the Investigator,
would compromise the patient's ability to safely complete the treatment protocol

- Known human immunodeficiency virus positivity, as neutropenia caused by eribulin
treatment may make such patients particularly susceptible to infection.

- Meningeal carcinomatosis

- Pulmonary lymphangitic involvement resulting in pulmonary dysfunction requiring
active treatment, including use of oxygen

- Receipt of any of the following treatments within the specified period before the
start of treatment: 1) Any investigational drug within 4 weeks; 2) Chemotherapy,
radiation, biological or targeted therapy within 2 weeks; 3) Hormonal therapy within
1 week.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Eribulin Mesylate

Secondary ID(s)

E7389-G000-398

Source(s) of Monetary Support

Please refer to primary and secondary sponsors