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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT02154139 (opens ClinicalTrials.gov in a new tab)Other id265-201Other idJapicCTI-142516Other idJapicCTI-R150796
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
651 participants (actual)
Sponsor
Takeda · Industry
Design
Not stated
Countries
Not stated
Start
Dec 2005
Primary completion
Mar 2010
Completion
Mar 2010
First posted
3 Jun 2014 (estimated)
Last update posted
17 Feb 2016 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008200920102011
  1. Ph –

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

    NCT02154139

    Dec 2005 to Mar 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Leuprorelin acetateDrug

Arms1

  • Other

    leuprorelin acetate

    Subcutaneous administration of leuprorelin acetate once every 12 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants Reporting One or More Adverse Drug Reactions

    Time frame · Baseline up to 96 weeks

    Registry description

    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.

  2. Number of Participants Reporting One or More Serious Adverse Drug Reactions

    Time frame · Baseline up to 96 weeks

    Registry description

    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

Secondary outcomes(3)

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

    Time frame · Week 24, 48,96

    Registry description

    Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (\>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of \>= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.

  2. Percentage of Participants With Progression Free Survival

    Time frame · Baseline up to 96 weeks

    Registry description

    Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.

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

    Time frame · Baseline up to 96 weeks

    Registry description

    Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to 96 weeks

Number of Participants Reporting One or More Adverse Drug Reactions

GroupValue (participants)
Leuprorelin Acetate128
Primary outcomeNumber· Baseline up to 96 weeks

Number of Participants Reporting One or More Serious Adverse Drug Reactions

GroupValue (participants)
Leuprorelin Acetate1
Secondary and other outcome results(3)
Secondary outcomeNumber· Week 24, 48,96

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

GroupValue (percentage of participants)
Leuprorelin Acetate10.34
Secondary outcomeNumber· Baseline up to 96 weeks

Percentage of Participants With Progression Free Survival

GroupValue (percentage of participants)
Leuprorelin Acetate49.68
Secondary outcomeNumber· Baseline up to 96 weeks

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

GroupValue (percentage of participants)
Leuprorelin Acetate95.37

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprorelin AcetateLeuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.–20 / 64476 / 644

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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