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Trial record 1 of 1 for:    Stimuvax | breast cancer
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STRIDE - STimulating Immune Response In aDvanced brEast Cancer (STRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00925548
Recruitment Status : Terminated (See termination reason in the below Purpose statement)
First Posted : June 22, 2009
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: Tecemotide (L-BLP25) and Hormonal Treatment
Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment
Drug: cyclophosphamide
Drug: sodium chloride (NaCl)
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented. Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Period Title: Overall Study
Started 11 5
Completed 1 0
Not Completed 10 5
Reason Not Completed
Discontinuation of trial by sponsor             10             5
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L Total
Hide Arm/Group Description Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented. Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented. Total of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
Safety population included all participants who received at least one dose of any study treatment (L-BLP25, placebo, cyclophosphamide, saline, or any of the three hormonal therapies).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Less than (<) 65 years 5 2 7
Greater than or equal to (>=) 65 years 6 3 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
11
 100.0%
5
 100.0%
16
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.
Time Frame Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival (OS) Time
Hide Description OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.
Time Frame Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With Objective Tumor Response
Hide Description Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.
Time Frame Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.
Time Frame Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With Clinical Benefit
Hide Description Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.
Time Frame Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).
Time Frame Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Time to Chemotherapy
Hide Description Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.
Time Frame Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire
Hide Description FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.
Time Frame Baseline, Week 9, 20, 32, 44 and end of trial visit
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title European Questionnaire-5 Dimensions (EQ-5D) Questionnaire
Hide Description EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.
Time Frame Baseline, Week 9, 20, 32, 44 and end of trial visit
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Participant Utilizing Healthcare Resources
Hide Description Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).
Time Frame Randomization up to end of trial visit
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Serum Carcinoma Antigen (CA) 15-3 Levels
Hide Description CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.
Time Frame Baseline, Week 5, 9, 20, 32, 44 and end of trial visit
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline (First treatment dose) up to end of trial i.e. 27 Aug 2010
Adverse Event Reporting Description Adverse event (AE): Any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.
 
Arm/Group Title Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Hide Arm/Group Description Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented. Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
All-Cause Mortality
Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Affected / at Risk (%) Affected / at Risk (%)
Total   1/11 (9.09%)   0/5 (0.00%) 
Gastrointestinal disorders     
Intestinal obstruction * 1  1/11 (9.09%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Placebo + Hormonal Therapy + NaCl 9 g/L
Affected / at Risk (%) Affected / at Risk (%)
Total   9/11 (81.82%)   3/5 (60.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/11 (9.09%)  0/5 (0.00%) 
Cardiac disorders     
Bradycardia * 1  1/11 (9.09%)  0/5 (0.00%) 
Eye disorders     
Eye swelling * 1  0/11 (0.00%)  1/5 (20.00%) 
Ocular hyperaemia * 1  0/11 (0.00%)  1/5 (20.00%) 
Vision blurred * 1  1/11 (9.09%)  0/5 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  7/11 (63.64%)  1/5 (20.00%) 
Vomiting * 1  3/11 (27.27%)  1/5 (20.00%) 
Abdominal pain * 1  3/11 (27.27%)  0/5 (0.00%) 
Constipation * 1  3/11 (27.27%)  0/5 (0.00%) 
Diarrhoea * 1  2/11 (18.18%)  0/5 (0.00%) 
Abdominal distension * 1  1/11 (9.09%)  0/5 (0.00%) 
Abdominal pain upper * 1  1/11 (9.09%)  0/5 (0.00%) 
Eructation * 1  1/11 (9.09%)  0/5 (0.00%) 
Odynophagia * 1  1/11 (9.09%)  0/5 (0.00%) 
General disorders     
Fatigue * 1  4/11 (36.36%)  0/5 (0.00%) 
Injection site erythema * 1  3/11 (27.27%)  0/5 (0.00%) 
Asthenia * 1  1/11 (9.09%)  1/5 (20.00%) 
Injection site haematoma * 1  0/11 (0.00%)  1/5 (20.00%) 
Injection site induration * 1  1/11 (9.09%)  0/5 (0.00%) 
Injection site pain * 1  1/11 (9.09%)  0/5 (0.00%) 
Injection site pruritus * 1  1/11 (9.09%)  0/5 (0.00%) 
Injection site swelling * 1  1/11 (9.09%)  0/5 (0.00%) 
Non-cardiac chest pain * 1  1/11 (9.09%)  0/5 (0.00%) 
Oedema peripheral * 1  1/11 (9.09%)  0/5 (0.00%) 
Chills * 1  1/11 (9.09%)  0/5 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  3/11 (27.27%)  0/5 (0.00%) 
Influenza * 1  1/11 (9.09%)  0/5 (0.00%) 
Upper respiratory tract infection * 1  0/11 (0.00%)  1/5 (20.00%) 
Urinary tract infection * 1  1/11 (9.09%)  0/5 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/11 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/11 (9.09%)  0/5 (0.00%) 
Hypercholesterolaemia * 1  1/11 (9.09%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain * 1  3/11 (27.27%)  0/5 (0.00%) 
Back pain * 1  2/11 (18.18%)  0/5 (0.00%) 
Arthralgia * 1  1/11 (9.09%)  0/5 (0.00%) 
Musculoskeletal chest pain * 1  1/11 (9.09%)  0/5 (0.00%) 
Myalgia * 1  0/11 (0.00%)  1/5 (20.00%) 
Nervous system disorders     
Dizziness * 1  2/11 (18.18%)  0/5 (0.00%) 
Headache * 1  1/11 (9.09%)  0/5 (0.00%) 
Hypoaesthesia * 1  1/11 (9.09%)  0/5 (0.00%) 
Sinus headache * 1  1/11 (9.09%)  0/5 (0.00%) 
Transient ischaemic attack * 1  1/11 (9.09%)  0/5 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/11 (9.09%)  1/5 (20.00%) 
Depression * 1  1/11 (9.09%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Painful respiration * 1  1/11 (9.09%)  0/5 (0.00%) 
Rhinorrhoea * 1  1/11 (9.09%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Night sweats * 1  2/11 (18.18%)  0/5 (0.00%) 
Alopecia * 1  0/11 (0.00%)  1/5 (20.00%) 
Nail disorder * 1  1/11 (9.09%)  0/5 (0.00%) 
Swelling face * 1  0/11 (0.00%)  1/5 (20.00%) 
Vascular disorders     
Hot flush * 1  2/11 (18.18%)  0/5 (0.00%) 
Hypertension * 1  1/11 (9.09%)  0/5 (0.00%) 
Jugular vein thrombosis * 1  1/11 (9.09%)  0/5 (0.00%) 
Phlebitis * 1  1/11 (9.09%)  0/5 (0.00%) 
Thrombophlebitis superficial * 1  1/11 (9.09%)  0/5 (0.00%) 
Thrombosis * 1  0/11 (0.00%)  1/5 (20.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 12.1
Efficacy data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00925548    
Other Study ID Numbers: EMR 200038-010
2008-005544-17 ( EudraCT Number )
First Submitted: June 17, 2009
First Posted: June 22, 2009
Results First Submitted: June 24, 2014
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014