Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00925548
Ethics application status
Date submitted
17/06/2009
Date registered
22/06/2009
Date last updated
24/07/2014

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
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tecemotide (L-BLP25) and Hormonal Treatment
Treatment: Other - 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)


Treatment: Other: 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)

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
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
Secondary outcome [1] 0 0
Overall Survival (OS) Time
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
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
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
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)
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
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
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
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
Timepoint [9] 0 0
Randomization up to end of trial visit
Secondary outcome [10] 0 0
Serum Carcinoma Antigen (CA) 15-3 Levels
Timepoint [10] 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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
16
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00925548