Overview

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

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Leuprolide
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.