Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)

To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer

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Key information

Conditions

Inoperable or Recurrent Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anjo, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inoperable breast cancer
Recurrent breast cancer

Exclusion criteria

Corresponding to contraindication of eribulin mesylate
Not applicable to indications of eribulin mesylate
Not applicable to aggravation or recurrence of breast cancer in patients who have previously been treated with anthracycline and/or taxane antitumor drugs

Treatment and study plan

eribulin mesylate

Drug

The usual adult dose of eribulin mesylate is 1.4 mg/m^2 (body surface area) administered intravenously over 2 to 5 minutes, once daily once a week. Treatment shall be continued for 2 consecutive weeks followed by a third week of drug cessation. With each cycle lasting 3 weeks, the treatment shall be repeated. The dose may be reduced, depending on the condition of the individual patient.

Primary outcomes

Effectiveness Diagnosed by Imaging

Time frame: 1 year
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 nontarget) must have reduction in short axis to less than10 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).

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Nov 2, 2011
Registry last updated: Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed