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Phase II Continuation Study of E7389 for Advanced or Relapsed Breast Cancer

Phase 2
20 Years
74 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Continuation Study of E7389 for Advanced or Relapsed Breast Cancer

During the period of E7389 administration, the following items will be examined to evaluate
the safety of E7389: signs and symptoms, clinical laboratory parameters, chest x-ray
findings, 12-lead ECG, vital signs, body weight, and adverse events. To evaluate the
efficacy of E7389, tumor lesions will be observed and tumor markers will be examined.

Inclusion Criteria

Inclusion criteria;

1. Female patients in whom continued administration of E7389 following the preceding
study will be useful.

2. Patients who have given written voluntary consent for participating in this study
before the completion of the preceding study.

3. Patients who have met the criteria for starting the next cycle in the preceding

Namely, patients who meet all of the following criteria:

1. Neutrophil count >= 1,500 /µL

2. Platelet count >= 100,000 /µL

3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the
upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with
hepatic metastasis)

4. Total bilirubin <= 1.5 times ULN

5. Serum creatinine <= 1.5 times ULN

6. Non-hematological toxicity <= Grade 2 (excluding disease-associated events and
laboratory abnormalities without clinical symptoms) Exclusion criteria;

Exclusion criteria:

1. Patients who are judged by the principal investigator or the other investigators to
be inappropriate as patients in this clinical study.

2. Pregnant women, nursing mothers, or premenopausal women of childbearing potential.
Premenopausal women of childbearing potential are defined as women who are <12 months
after the latest menstruation and are positive in pregnancy test performed for
enrollment or who have not taken the test and do not consent to take an appropriate
contraceptive measure. Post-menopausal women must be amenorrheic for at least 12
months to make sure that they have no potential for becoming pregnant.

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:

Occurrence of adverse events, changes in physical examination findings, laboratory test results, vital signs, and electrocardiogram evaluations.

Outcome Time Frame:

Every week

Safety Issue:


Principal Investigator

Tatsuo Watanabe

Investigator Role:

Study Director

Investigator Affiliation:

Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

August 2009

Completion Date:

November 2010

Related Keywords:

  • Breast Cancer
  • Cancer
  • breast cancer
  • neoplasm
  • E7389
  • Eribulin
  • Breast Neoplasms