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

Inclusion Criteria:

1. Female patients with histologically or cytologically confirmed breast cancer.

2. The patients who have received prior chemotherapy including anthracycline and taxane.

3. Patients aged 20 - 74 years when giving informed consent.

4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
0 to 2.

5. Patients with a measurable lesion.

6. Patients having adequate function of major organs (bone marrow, liver, kidney and

7. Patients who have no carryover of efficacy or no adverse drug reactions from previous
therapy that may affect the safety evaluation of the study drug.

8. Patients who have given written voluntary consent for participation in this study.

9. Patients with an expected survival of ≥ 3 months from the start of study drug

Exclusion Criteria:

1. Patients with systemic infection with a fever ≥38.0°C).

2. Patients with pleural effusion, ascites or pericardial fluid requiring drainage.

3. Patients with brain metastasis presenting clinical symptoms.

4. Patients with serious complications:

- (1) Patients with uncontrollable cardiac disease such as ischemic heart disease
and arrhythmia at a level of severity that needs to be treated (excluding left
ventricular hypertrophy, mild left ventricular volume overload and mild right
leg block that accompany hypertension)

- (2) Patients with myocardial infarction within 6 months prior to study entry

- (3) Patients with a complication of hepatic cirrhosis

- (4) Patients with interstitial pneumonia and pulmonary fibrosis

- (5) Patients with a bleeding tendency

5. Patients with an active double cancer.

6. Pregnant women or nursing mothers.

7. Patients who have received extensive radiotherapy (≥30% of bone marrow).

8. Patients who refuse to receive the supportive therapy of blood transfusion for

9. Patients who are participating in other clinical studies.

10. Patients who are judged inappropriate for this study by the investigator or

Type of Study:


Study Design:

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

Outcome Measure:

Percent of Subjects With Objective Response

Outcome Description:

Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Tatsuo Watanabe

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

January 2008

Completion Date:

September 2009

Related Keywords:

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