Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Effectiveness Diagnosed by Imaging

Outcome Description:

Effectiveness diagnosed by imaging, is based on Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Defined as: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Not Evaluable (NE).

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Toshiyuki Matsuoka

Investigator Role:

Study Director

Investigator Affiliation:

Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

HAL01S

NCT ID:

NCT01463891

Start Date:

July 2011

Completion Date:

March 2014

Related Keywords:

• Inoperable or Recurrent Breast Cancer
• Eribulin Mesylate
• inoperable or recurrent breast cancer
• Breast Neoplasms