NCT02154139

Brief 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 milligram (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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 17, 2016

Completed
Last Updated

February 17, 2016

Status Verified

January 1, 2016

Enrollment Period

4.2 years

First QC Date

April 23, 2014

Results QC Date

January 19, 2016

Last Update Submit

January 19, 2016

Conditions

Breast Cancer

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Reporting One or More Adverse Drug Reactions

    Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

    Baseline up to 96 weeks

  • Number of Participants Reporting One or More Serious Adverse Drug Reactions

    Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female

    Baseline up to 96 weeks

Secondary Outcomes (3)

  • Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)

    Week 24, 48,96

  • Percentage of Participants With Progression Free Survival

    Baseline up to 96 weeks

  • Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy

    Baseline up to 96 weeks

Study Arms (1)

leuprorelin acetate

Subcutaneous administration of leuprorelin acetate once every 12 weeks

Drug: Leuprorelin acetate

Interventions

Leuprorelin acetateDRUG

Leuprorelin acetate SR 11.25 mg for injection

Also known as: Leuplin SR 11.25 mg for Injection
leuprorelin acetate

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer

You may qualify if:

  • Premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy).

You may not qualify if:

  • Patients with a history of treatment with Leuplin SR 11.25 mg for Injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LeuprolideInjections

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsDrug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Postmarketing Group Manager

    Takeda

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

June 3, 2014

Study Start

December 1, 2005

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 17, 2016

Results First Posted

February 17, 2016

Record last verified: 2016-01