N/A
Completed N=2,816
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
Source: ClinicalTrials.gov NCT02134977 ↗Enrolled (actual)
2,816
Serious AEs
0.3%
Results posted
Oct 2016
Primary outcomePrimary: Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline — 88.9; 28.0; 21.9; 19.1 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline |
88.9; 28.0; 21.9; 19.1; 16.0 | — |
| PRIMARY QOL-ACD Total and Subscale Score at Week 12 |
88.7; 27.9; 21.8; 18.8; 16.3 | — |
| PRIMARY QOL-ACD Total and Subscale Score at Week 48 |
89.9; 28.1; 22.2; 19.1; 16.6 | — |
| PRIMARY QOL-ACD Breast (QOL-ACD-B) Score at Baseline |
70.4; 72.3; 85.1 | — |
| PRIMARY Score of QOL-ACD-B at Week 12 |
71.0; 73.1; 85.2 | — |
| PRIMARY Score of QOL-ACD-B at Week 48 |
71.9; 74.8; 84.9 | — |
| PRIMARY Score of QOL-ACD-B Items 19, 20 and 21 at Baseline |
3.3; 2.9; 1.7 | — |
| PRIMARY Score of QOL-ACD-B Items 19, 20 and 21 at Week 12 |
3.5; 3.3; 1.8 | — |
| PRIMARY Score of QOL-ACD-B Items 19, 20 and 21 at Week 48 |
3.5; 3.2; 1.7 | — |
| SECONDARY Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents |
67.7; 10.1; 16.9; 5.3 | — |
| SECONDARY Percentage of Participants Who Felt Relief From Physical and Emotional Burden |
34.8; 31.6; 17.8; 7.1; 4.8; 3.9 | — |
| SECONDARY Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents |
22.2; 41.0; 21.2; 9.5; 2.4; 3.6 | — |
| SECONDARY Percentage of Participants Who Worried About the Effect of the Medicinal Agent |
29.7; 33.8; 22.4; 9.8; 0.8; 3.5 | — |
| SECONDARY Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents |
1.4; 5.5; 68.5; 17.0; 3.9; 3.7 | — |
| SECONDARY Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents |
4.7; 10.4; 64.9; 14.4; 2.1; 3.5 | — |
| SECONDARY Percentage of Participants With Positive Change in Agents |
32.0; 36.5; 26.0; 1.3; 0.5; 3.7 | — |
| SECONDARY Number of Participants Reporting One or More Adverse Drug Reactions |
427 | — |
| SECONDARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
8 | — |
Eligibility Criteria
Inclusion Criteria
- Premenopausal breast cancer participants who meet all the following criteria are to be enrolled in the surveillance:
- 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.
- Participants receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy.
- Participants with performance status grade of 0 or 1.
- 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:
- 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.
- Pregnant women, possibly pregnant women, and nursing mothers.
- 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.
Data sourced from ClinicalTrials.gov (NCT02134977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.