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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209518
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.

Condition or disease Intervention/treatment
Premenopausal Breast Cancer Drug: Leuprorelin acetate

Detailed Description:

The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have premenopausal breast cancer.

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

The study will enroll approximately 300 patients.

• Leuprorelin acetate

This multi-center trial will be conducted in Japan.


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Study Type : Observational
Actual Enrollment : 312 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Actual Study Start Date : March 18, 2016
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Leuprorelin acetate
Usually, for adults, 22.5 mg of Leuprorelin Acetate is subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants will receive interventions as part of routine medical care.
Drug: Leuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Other Name: Leuplin PRO for Injection Kit 22.5 mg




Primary Outcome Measures :
  1. Percentage of participants who had one or more adverse events [ Time Frame: Up to Week 24 ]
    Time frame is defined the duration from the start of treatment with Leuprorelin acetate injection up to 24 weeks after the start of treatment (or at the time the observation is discontinued).


Secondary Outcome Measures :
  1. Percentage of participants who had one or more adverse drug reactions [ Time Frame: Up to Week 24 ]
    Adverse drug reaction refers to adverse events related to administered drug. Time frame is defined the duration from the start of treatment with Leuprorelin acetate injection up to 24 weeks after the start of treatment (or at the time the observation is discontinued).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of participants with a diagnosis of premenopausal breast cancer and received dose of Leuplin PRO for Injection Kit 22.5 mg/Leuprorelin acetate in the routine medical care.
Criteria

Inclusion Criteria:

  • Participants with premenopausal breast cancer will be included.

Exclusion Criteria:

  • Participants with a previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
  • Pregnant women or women who are possibly pregnant, or nursing mothers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209518


Locations
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Japan
Takeda selected site
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Chair: Postmarketing Group Manager Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03209518     History of Changes
Other Study ID Numbers: Leuprorelin-5003
JapicCTI-163203 ( Registry Identifier: JapicCTI )
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents