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STRIDE - STimulating Immune Response In aDvanced brEast Cancer

This study has been terminated.
(See termination reason in the below Purpose statement)
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00925548
First received: June 17, 2009
Last updated: July 23, 2014
Last verified: July 2014
Results First Received: June 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide 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.
Placebo + Hormonal Therapy + NaCl 9 g/L 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.

Participant Flow:   Overall Study
    Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide     Placebo + Hormonal Therapy + NaCl 9 g/L  
STARTED     11     5  
COMPLETED     1     0  
NOT COMPLETED     10     5  
Discontinuation of trial by sponsor                 10                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide 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.
Placebo + Hormonal Therapy + NaCl 9 g/L 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 Total of all reporting groups

Baseline Measures
    Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide     Placebo + Hormonal Therapy + NaCl 9 g/L     Total  
Number of Participants  
[units: participants]
  11     5     16  
Age, Customized  
[units: participants]
     
Less than (<) 65 years     5     2     7  
Greater than or equal to (>=) 65 years     6     3     9  
Gender  
[units: participants]
     
Female     11     5     16  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ 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 ]

2.  Secondary:   Overall Survival (OS) Time   [ 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 ]

3.  Secondary:   Percentage of Participants With Objective Tumor Response   [ Time Frame: Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010 ]

4.  Secondary:   Duration of Response   [ 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 ]

5.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010 ]

6.  Secondary:   Time to Progression (TTP)   [ 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 ]

7.  Secondary:   Time to 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 ]

8.  Secondary:   Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire   [ Time Frame: Baseline, Week 9, 20, 32, 44 and end of trial visit ]

9.  Secondary:   European Questionnaire-5 Dimensions (EQ-5D) Questionnaire   [ Time Frame: Baseline, Week 9, 20, 32, 44 and end of trial visit ]

10.  Secondary:   Number of Participant Utilizing Healthcare Resources   [ Time Frame: Randomization up to end of trial visit ]

11.  Secondary:   Serum Carcinoma Antigen (CA) 15-3 Levels   [ Time Frame: Baseline, Week 5, 9, 20, 32, 44 and end of trial visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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)


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


No publications provided


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00925548     History of Changes
Other Study ID Numbers: EMR 200038-010, 2008-005544-17
Study First Received: June 17, 2009
Results First Received: June 24, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
India: Ministry of Health
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Authority of Medicines and Health Products (INFARMED, I.P.)
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Department of Health
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency