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

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Leuprorelin acetate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Postmarketing Group Manager, Study Chair, Affiliation: Takeda

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Changes in QOL

Secondary outcome: Frequency of adverse drug reactions

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 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: October 2011
Last updated: April 1, 2015

Page last updated: August 23, 2015

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