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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134977
• Other study ID #: 265-211
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: April 1, 2015
• Start date: October 2011
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

The purpose of this survey is to examine the effect on QOL improvement and convenience of switching to Leuprorelin acetate 3 moths 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 patients 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.

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 patients 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2816
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

1. Patients 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. Patients receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy

3. Patients with performance status grade of 0 or 1

4. Patients 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:

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

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

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

3. Patients 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Leuprorelin acetate
Leuprorelin acetate SR 11.25 mg Injection Kit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in QOL	For the efficacy analysis set, the following parameters will be tabulated: changes in QOL (QOL-ACD score, QOL-ACD-B score, patient impression to switching medication) from baseline to 48 weeks of treatment will be tabulated.	From baseline to 48 weeks of treatment	No
Secondary	Frequency of adverse drug reactions	The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of leuprorelin acetate whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with leuprorelin acetate are defined as adverse drug reactions.	For 48 weeks	Yes