Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

October 9, 2019 updated by: Takeda

Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.

This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.

The survey will enroll approximately 300 patients.

- Leuprorelin

This multi-center survey will be conducted in Japan.

Study Type

Observational

Enrollment (Actual)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Takeda Selected Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The survey population will consist of participants with a diagnosis of premenopausal breast cancer and received dose of Leuprorelin for Injection Kit 22.5 mg in the routine medical care.

Description

Inclusion Criteria:

- Participants with premenopausal breast cancer will be included.

Exclusion Criteria:

  • Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
  • Pregnant or potentially pregnant participants and breastfeeding participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Leuprorelin acetate
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
Drug: Leuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Other Names:
  • Leuplin PRO for Injection Kit 22.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Had One or More Adverse Events
Time Frame: Up to Week 24
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Had One or More Adverse Reactions
Time Frame: Up to Week 24
Adverse drug reaction refers to adverse events related to the administered drug.
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2016

Primary Completion (ACTUAL)

October 10, 2018

Study Completion (ACTUAL)

October 10, 2018

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (ACTUAL)

July 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leuprorelin-5003
  • JapicCTI-163203 (REGISTRY: JapicCTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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