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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00925548




Registration number
NCT00925548
Ethics application status
Date submitted
17/06/2009
Date registered
18/06/2009
Date last updated
23/07/2014

Titles & IDs
Public title
STRIDE - STimulating Immune Response In aDvanced brEast Cancer
Scientific 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
Secondary ID [1] 0 0
2008-005544-17
Secondary ID [2] 0 0
EMR 200038-010
Universal Trial Number (UTN)
Trial acronym
STRIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Tecemotide (L-BLP25) and Hormonal Treatment
Other interventions - Placebo of tecemotide (L-BLP25) and Hormonal Treatment
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - sodium chloride (NaCl)
Other interventions - Tecemotide (L-BLP25) and Hormonal Treatment
Other interventions - Placebo of tecemotide (L-BLP25) and Hormonal Treatment
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - sodium chloride (NaCl)

Experimental: Investigational Arm - Investigational Arm:
Pretreatment (Single Dose): 300 milligrams per square meter (mg/m^2) up to a maximum dose of 600 mg of intravenous cyclophosphamide
tecemotide (L-BLP25) plus Hormonal Therapy (Standard Dose)

Active Comparator: Control Arm - Control Arm:
Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/L) infusion
Placebo plus Hormonal Therapy (Standard Dose)

Experimental: Investigational Arm - Investigational Arm:
Pretreatment (Single Dose): 300 milligrams per square meter (mg/m^2) up to a maximum dose of 600 mg of intravenous cyclophosphamide
tecemotide (L-BLP25) plus Hormonal Therapy (Standard Dose)

Active Comparator: Control Arm - Control Arm:
Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/L) infusion
Placebo plus Hormonal Therapy (Standard Dose)


Other interventions: Tecemotide (L-BLP25) and Hormonal Treatment
Investigational Arm:
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)

Other interventions: Placebo of tecemotide (L-BLP25) and Hormonal Treatment
Control Arm:
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).

Treatment: Drugs: cyclophosphamide
300 mg/m^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.

Treatment: Drugs: sodium chloride (NaCl)
NaCl 9 g/L infusion

Other interventions: Tecemotide (L-BLP25) and Hormonal Treatment
Investigational Arm:
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)

Other interventions: Placebo of tecemotide (L-BLP25) and Hormonal Treatment
Control Arm:
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).

Treatment: Drugs: cyclophosphamide
300 mg/m^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.

Treatment: Drugs: sodium chloride (NaCl)
NaCl 9 g/L infusion

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) - PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Progression-Free Survival (PFS) - PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.
Timepoint [2] 0 0
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
Secondary outcome [1] 0 0
Overall Survival (OS) Time - 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.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Percentage of Participants With Objective Tumor Response - 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.
Timepoint [2] 0 0
Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010
Secondary outcome [3] 0 0
Duration of Response - 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.
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Benefit - 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.
Timepoint [4] 0 0
Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010
Secondary outcome [5] 0 0
Time to Progression (TTP) - TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Time to Chemotherapy - Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire - 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.
Timepoint [7] 0 0
Baseline, Week 9, 20, 32, 44 and end of trial visit
Secondary outcome [8] 0 0
European Questionnaire-5 Dimensions (EQ-5D) Questionnaire - 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.
Timepoint [8] 0 0
Baseline, Week 9, 20, 32, 44 and end of trial visit
Secondary outcome [9] 0 0
Number of Participant Utilizing Healthcare Resources - 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).
Timepoint [9] 0 0
Randomization up to end of trial visit
Secondary outcome [10] 0 0
Serum Carcinoma Antigen (CA) 15-3 Levels - CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.
Timepoint [10] 0 0
Baseline, Week 5, 9, 20, 32, 44 and end of trial visit
Secondary outcome [11] 0 0
Overall Survival (OS) Time - 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.
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Percentage of Participants With Objective Tumor Response - 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.
Timepoint [12] 0 0
Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010
Secondary outcome [13] 0 0
Duration of Response - 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.
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
Percentage of Participants With Clinical Benefit - 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.
Timepoint [14] 0 0
Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010
Secondary outcome [15] 0 0
Time to Progression (TTP) - TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Time to Chemotherapy - Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire - 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.
Timepoint [17] 0 0
Baseline, Week 9, 20, 32, 44 and end of trial visit
Secondary outcome [18] 0 0
European Questionnaire-5 Dimensions (EQ-5D) Questionnaire - 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.
Timepoint [18] 0 0
Baseline, Week 9, 20, 32, 44 and end of trial visit
Secondary outcome [19] 0 0
Number of Participant Utilizing Healthcare Resources - 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).
Timepoint [19] 0 0
Randomization up to end of trial visit
Secondary outcome [20] 0 0
Serum Carcinoma Antigen (CA) 15-3 Levels - CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.
Timepoint [20] 0 0
Baseline, Week 5, 9, 20, 32, 44 and end of trial visit

Eligibility
Key inclusion criteria
- Postmenopausal women as defined in the protocol

- Estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive,
histologically or cytologically confirmed primary carcinoma of the breast

- Expressing at least one of the following five human leukocyte antigen (HLA)
haplotypes, as centrally assessed by HLA genotyping from whole blood: HLA-A2, -A3,
-A11, -B7, or -B35

- Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least
one lesion not located in bone)

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), and
inoperable

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate hematologic, hepatic, and renal function within two weeks prior to initiation
of therapy, as defined by the protocol

- Other protocol-defined inclusion criteria may apply
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Disease Status

- PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within
48 months from the initiation of such therapy

- Human epidermal growth factor receptor 2-positive (HER2+) breast cancer as defined in
the protocol

- Autoimmune disease that in the opinion of the investigator could compromise the safety
of the subject in this study (Exception will be granted for well-controlled Type I
diabetes mellitus)

- Recognized immunodeficiency disease, including cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital
immunodeficiencies

- Past or current history of malignant neoplasm other than breast cancer (BRCA), except
for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or
other cancer curatively treated and with no evidence of disease for at least five
years

- Known active Hepatitis B infection or carrier state and/or Hepatitis C infection,
known Human Immunodeficiency Virus infection, or any other infectious process that in
the opinion of the investigator could compromise the subject's ability to mount an
immune response or could expose her to the likelihood of more and/or severe side
effects

Pre-therapies

- Receipt of immunotherapy (for example [e.g.], interferons; tumor necrosis factor;
interleukins; growth factors granulocyte macrophage-colony stimulating factor
[GM-CSF], granulocyte-colony stimulating factor [G-CSF], macrophage-colony stimulating
factor [M-CSF], or monoclonal antibodies), or chemotherapy, within four weeks (28
days) prior to randomization. Note: Subjects who have received monoclonal antibodies
for imaging are eligible

- Prior receipt of investigational systemic drugs (including off-label use of approved
products) or any kind of systemic treatment (chemotherapy, or immunotherapy), with the
exception of hormonal therapy (HT) when given for a period not exceeding 4 weeks (28
days) prior to randomization, for treatment of inoperable, locally advanced,
recurrent, or metastatic breast cancer

- Prior radiotherapy to the site of cancer, if only one site will be used for evaluation
of tumor response

Prior use of bisphosphonates or concurrent use while on study treatment is allowed

Physiological Function

- Central nervous system disease or brain metastases, as documented by computed
tomography (CT) or magnetic resonance imaging (MRI)

- Medical or psychiatric conditions that would interfere with the ability to provide
informed consent, communicate side effects, or comply with protocol requirements

- Clinically significant cardiac disease, e.g., cardiac failure of New York Heart
Association (NYHA) classes III-IV; uncontrolled angina pectoris, uncontrolled
arrhythmia, uncontrolled hypertension, or myocardial infarction in the previous six
months, as confirmed by an electrocardiogram (ECG)

- Splenectomy

Standard Criteria

- Need for concurrent treatment with a non-permitted therapy (e.g., concurrent
chemotherapy, radiotherapy, systemic immunosuppressive drugs, use of herbal medicines
or botanical formulations intended to treat cancer) while on protocol therapy.
Palliative radiation to painful bone lesions is allowed

- Participation in another clinical study within 30 days prior to randomization

- Known hypersensitivity to the study drugs

- Known alcohol or drug abuse

- Legal incapacity or limited legal capacity

- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.

- Subject who could be regarded as "vulnerable" according to International Conference on
Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (e.g., the subject's
willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or
of a retaliatory response from senior members of a hierarchy in case of refusal to
participate, plus persons kept in detention; persons in nursing homes; subjects in
emergency situations; homeless persons; and nomads)

- Any other reason that, in the opinion of the investigator, precludes the subject from
participating in this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park, SA
Recruitment postcode(s) [1] 0 0
- Bedford Park, SA
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Pardubice
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
Germany
State/province [7] 0 0
Chemnitz
Country [8] 0 0
Germany
State/province [8] 0 0
Darmstadt
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt am Main
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Germany
State/province [11] 0 0
Kiel
Country [12] 0 0
Germany
State/province [12] 0 0
Lübeck
Country [13] 0 0
Germany
State/province [13] 0 0
München
Country [14] 0 0
Germany
State/province [14] 0 0
Rostock
Country [15] 0 0
Germany
State/province [15] 0 0
Tübingen
Country [16] 0 0
Germany
State/province [16] 0 0
Wiesbaden
Country [17] 0 0
Israel
State/province [17] 0 0
Beer Yaakov
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Gyeonggi-do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Poland
State/province [20] 0 0
Opole
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Obninsk
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Saint-Petersburg
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Tula
Country [24] 0 0
Slovakia
State/province [24] 0 0
Bratislava
Country [25] 0 0
Slovakia
State/province [25] 0 0
Nitra
Country [26] 0 0
Slovakia
State/province [26] 0 0
Poprad
Country [27] 0 0
Slovakia
State/province [27] 0 0
Trnava
Country [28] 0 0
South Africa
State/province [28] 0 0
Johannesburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the
indication of breast cancer following the clinical hold on the investigational new drug
application for tecemotide (L-BLP25).
Trial website
https://clinicaltrials.gov/show/NCT00925548
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oscar Kashala, MD, PhD, DSc
Address 0 0
EMD Serono
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00925548