An observational post-marketing surveillance study on the status and factors for the development of peripheral neuropathy in patients with HER2-negative inoperable or recurrent breast cancer in Japan (HAL02T)

Study identification

• EU PAS number:
  EUPAS7424
• Study ID:
  32353
• Official title and acronym:
  An observational post-marketing surveillance study on the status and factors for the development of peripheral neuropathy in patients with HER2-negative inoperable or recurrent breast cancer in Japan (HAL02T)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Patients with HER-2 negative inoperable or recurrent breast cancer treated with eribulin will be followed for up to two years to evaulate the incidence of peripheral neuropathy and any factors that influence the incidence. CTCAE grade of peripheral neuropathy will be assessed at baseline and every two months after initiation of treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/09/2014

Actual: 01/09/2014

Study start date

Planned: 30/09/2014

Actual: 29/09/2014

Date of final study report

Planned: 28/06/2019

Actual: 25/02/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only