Clinical trial NCT02134977: Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
Official title: Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 2816
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer

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.

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.

Primary outcomes:
measure: Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline
timeFrame: Baseline
measure: QOL-ACD Total and Subscale Score at Week 12
timeFrame: Week 12
measure: QOL-ACD Total and Subscale Score at Week 48
timeFrame: Week 48
measure: QOL-ACD Breast (QOL-ACD-B) Score at Baseline
timeFrame: Baseline
measure: Score of QOL-ACD-B at Week 12
timeFrame: Week 12
measure: Score of QOL-ACD-B at Week 48
timeFrame: Week 48
measure: Score of QOL-ACD-B Items 19, 20 and 21 at Baseline
timeFrame: Baseline
measure: Score of QOL-ACD-B Items 19, 20 and 21 at Week 12
timeFrame: Week 12
measure: Score of QOL-ACD-B Items 19, 20 and 21 at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents
timeFrame: Week 48
measure: Percentage of Participants Who Felt Relief From Physical and Emotional Burden
timeFrame: Week 48
measure: Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents
timeFrame: Week 48
measure: Percentage of Participants Who Worried About the Effect of the Medicinal Agent
timeFrame: Week 48
measure: Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents
timeFrame: Week 48
measure: Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents
timeFrame: Week 48
measure: Percentage of Participants With Positive Change in Agents
timeFrame: Week 48
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to Week 48
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: