Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

NCT ID: NCT02134977

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2816 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice. Influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was also evaluated.

Detailed Description

This survey was designed to examine the effect on QOL improvement and convenience of switching to leuprorelin acetate 3 month depot 11.25 mg injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a LH-RHa 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice, as well as to evaluate the influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit .

For adults, leuprorelin acetate SR 11.25 mg injection kit (Leuplin SR 11.25 mg Injection Kit) is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Leuprorelin Acetate

Subcutaneous administration of leuprorelin acetate 11.25 mg once every 12 weeks

Leuprorelin Acetate

Intervention Type: DRUG

Leuprorelin Acetate SR 11.25 mg Injection Kit

Interventions

Leuprorelin Acetate

Leuprorelin Acetate SR 11.25 mg Injection Kit

Intervention Type: DRUG

Other Intervention Names

Leuplin SR 11.25 mg Injection Kit

Eligibility Criteria

Inclusion Criteria

• Premenopausal breast cancer participants who meet all the following criteria are to be enrolled in the surveillance:

1. Participants who received 4 weeks of treatment with a repository LH-RHa preparation within 1 week prior to administration of Leuplin SR 11.25 mg Injection Kit.

2. Participants receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy.

3. Participants with performance status grade of 0 or 1.

4. Participants who answered all of the questions on the "QOL check sheet (I)" at the start (Week 0) of treatment with Leuplin SR 11.25 mg Injection Kit.

Exclusion Criteria

• Participants who meet any of the following criteria are to be excluded from the surveillance:

1. Participants with a history of hypersensitivity to ingredient(s) in Leuplin SR 11.25 mg Injection Kit or synthetic derivatives of luteinizing hormone-releasing hormone (LH-RH) or LH-RH.

2. Pregnant women, possibly pregnant women, and nursing mothers.

3. Participants with advanced (T4 or M1 according to the TNM classification [General Rules for Clinical and Pathological Recording of Breast Cancer: 16th edition]) or recurrent breast cancer.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Postmarketing Group Manager

Role: STUDY_CHAIR

Takeda

Other Identifiers

JapicCTI-142513

Identifier Type: REGISTRY

Identifier Source: secondary_id

265-211

Identifier Type: -

Identifier Source: org_study_id