STRIDE - STimulating Immune Response In aDvanced brEast Cancer (STRIDE)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: Tecemotide (L-BLP25) and Hormonal Treatment Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment Drug: cyclophosphamide Drug: sodium chloride (NaCl)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Controlled Phase III Study of Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Combination With Hormonal Treatment Versus Hormonal Treatment Alone for First-line Therapy of Post-menopausal Women With Estrogen Receptor (ER)-Positive and/or Progesterone Receptor (PgR)-Positive, Inoperable Locally Advanced, Recurrent, or Metastatic Breast Cancer|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Experimental: Investigational Arm
Biological: Tecemotide (L-BLP25) and Hormonal Treatment
Pretreatment (Single Dose) 300 mg/m^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg).
Primary treatment phase:
Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)* (Week 1 to 8).
Maintenance treatment phase:
Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).
*calculated as mass of lipopeptide (antigen)
300 mg/m^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.
Active Comparator: Control Arm
Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment
Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide.
Primary treatment phase:
Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8).
Maintenance treatment phase:
Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).
Drug: sodium chloride (NaCl)
NaCl 9 g/L infusion
- 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 ]PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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 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 ]TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).
- 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 ]Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire [ Time Frame: Baseline, Week 9, 20, 32, 44 and end of trial visit ]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.
- European Questionnaire-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Baseline, Week 9, 20, 32, 44 and end of trial visit ]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.
- Number of Participant Utilizing Healthcare Resources [ Time Frame: Randomization up to end of trial visit ]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).
- Serum Carcinoma Antigen (CA) 15-3 Levels [ Time Frame: Baseline, Week 5, 9, 20, 32, 44 and end of trial visit ]CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925548
|United States, North Carolina|
|Hickory, North Carolina, United States|
|Bedford Park, SA, Australia|
|Pardubice, Czech Republic|
|Praha, Czech Republic|
|Frankfurt am Main, Germany|
|Beer Yaakov, Israel|
|Korea, Republic of|
|Gyeonggi-do, Korea, Republic of|
|Seoul, Korea, Republic of|
|Obninsk, Russian Federation|
|Saint-Petersburg, Russian Federation|
|Tula, Russian Federation|
|Johannesburg, South Africa|
|Study Director:||Oscar Kashala, MD, PhD, DSc||EMD Serono|