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Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies

18 Years
Not Enrolling
Breast Cancer

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Trial Information

Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies

This compassionate use program will consist of a Pretreatment Phase and a Treatment Phase.
Patients with locally advanced or metastatic breast cancer who fulfill the eligibility
criteria may be treated. Safety data will be collected, but a minimal amount of other data
will also be collected.

Inclusion Criteria

Inclusion Criteria

In order to receive eribulin under this protocol, the subjects oncologist must have
documented experience treating subjects with eribulin in a prior clinical study. Subjects
who meet all of the following criteria will be included in the treatment protocol:

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

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

- Anthracyclines, taxanes, and capecitabine.

- Ixabepilone in countries where this agent is marketed.

- Trastuzumab for Her-2 positive disease.

- Hormonal therapy in hormone receptor-positive disease.

- All other marketed therapies, eg, gemcitabine or vinorelbine, used for the
treatment of advanced breast cancer.1

3. Eastern Cooperative Oncology Group (ECOG) performance status < 2.

4. Serum creatinine < 2.0 mg/dL or creatinine clearance ?40 mL/min according to
Cockcroft and Gault formula.

5. Absolute neutrophil count >1.5 x 109/L, hemoglobin >10 g/dL (can be corrected by
growth factor or transfusion), and platelet count >100 x 109/L.

6. Total bilirubin <1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP),
alanine aminotransferase, and aspartate aminotransferase <3 x ULN (<5 x ULN in case
of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x
ULN (in presence of liver metastases) AND subject also is known to have bone
metastases, the liver specific AP must be separated from the total and used to assess
the liver function instead of the total AP.

7. Are willing and able to comply with all aspects of the treatment protocol.

8. Provide written informed consent.

9. Females, age >18 years.

10. Female subjects of childbearing potential must agree to be abstinent or to use a
highly effective methods of contraception (eg, condom + spermicide, condom +
diaphragm with spermicide, intra-uterine device, or have a vasectomised partner)
having started for at least one menstrual cycle prior to starting eribulin and
throughout the entire treatment period and for 30 days (longer if appropriate) after
the last dose of eribulin. Those women using hormonal contraceptives must also be
using an additional approved method of contraception (as described previously).
Perimenopausal women must be amenorrheic for at least 12 months to be considered of
non-childbearing potential.

Exclusion Criteria Subjects who meet any of the following criteria will be excluded from
participation in the treatment protocol:

1. Eligible for any other eribulin study that is open in the same region.

2. Existing anti-cancer therapy-related toxicities of Grade >2, except that alopecia and
Grade 2 neuropathy are acceptable.

3. History of congestive heart failure with New York Heart Association Classification
>II, unstable angina, myocardial infarction within the past 6 months, serious
cardiac arrhythmia.

4. Electrocardiogram with QTc interval >500 msec based upon Bazett?s formula (QTcB).

5. The Investigator believes the subject to be medically unfit to receive eribulin or
unsuitable for any other reason.

6. Females who are pregnant (positive B-hCG test) or breastfeeding.

7. Subject with hypersensitivity to eribulin or any of the excipients.

8. Subjects with brain or subdural metastases are not eligible, unless they have
completed local therapy and have discontinued the use of corticosteroids for this
indication for at least 4 weeks before starting treatment in this treatment protocol.
Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at
least 4 weeks before starting the treatment protocol.

9. Any history of or concomitant medical condition that, in the opinion of the
Investigator, would compromise the subject's ability to safely complete the treatment

10. Subjects who are known to be human immunodeficiency virus positive because the
neutropenia caused by the eribulin treatment may make such subjects particularly
susceptible to infection.

11. Subjects with meningeal carcinomatosis.

12. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring
active treatment, including the use of oxygen.

13. Subjects who have received any of the following treatments within the specified
period before the start of treatment:

- Any investigational drug, chemotherapy, radiation, or biological or targeted
therapy within 2 weeks.

- Hormonal therapy within 1 week.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

To provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator. Safety evaluation: population - all patients who receive at least a partial dose of eribulin. General safety will be assessed by monitoring and recording of all adverse events and serious adverse events, regular monitoring of hematology and blood chemistry, regular measurement of vital signs and performance of physical exams.

Outcome Time Frame:

up to 28 days

Safety Issue:


Principal Investigator

Eisai Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Advanced breast cancer refractory to all commercially available therapies
  • Breast Neoplasms



Fountain Valley, California  92708
Albany, New York  12208
Austin, Texas  78705
Charlotte, North Carolina  
Bismarck, North Dakota  58501