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Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

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 safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11. 25 mg for injection (Leuplin SR 11. 25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11. 25 mg for injection (Leuplin SR 11. 25 mg for Injection).

Clinical Details

Official title: Leuplin SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

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

Primary outcome: Frequency of adverse drug reactions

Secondary outcome:

Antitumor efficacy over the 96-week period of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection) in patients with advanced or recurrent breast cancer

Recurrence-free survival over the 96-week period of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection) in patients who were treated asadjuvant therapy

Detailed description: This survey was designed to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate 3 months depot for injection (Leuplin SR 11. 25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11. 25 mg for injection (Leuplin SR 11. 25 mg for Injection). For adults, 11. 25 mg of leuprorelin acetate 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 (patients with advanced or recurrent breast

cancer and patients who received adjuvant therapy). Exclusion Criteria:

- Patients with a history of treatment with Leuplin SR 11. 25 mg for Injection

Locations and Contacts

Additional Information

Starting date: December 2005
Last updated: May 29, 2014

Page last updated: August 23, 2015

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