| CTRI Number |
CTRI/2009/091/000660 [Registered on: 05/02/2010] |
| Last Modified On: |
21/03/2011 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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STRIDE - A Randomised, Double-Blind, Phase III Study of Stimuvax® in combination with Hormonal Treatment versus Hormonal Treatment alone for First-line Therapy of endocrine-sensitive Advanced Breast Cancer |
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Scientific Title of Study
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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
Acronym : STRIDE |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| 2008-005544-17 |
EudraCT |
| EMR 200038-010 |
Protocol Number |
| NTC00925548 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Venkataraghuram Muppavarapu |
| Designation |
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| Affiliation |
Senior Clinical Research Physician, Medical Affairs |
| Address |
ICON Clinical Research ( CRO)
Campus 3A - 2nd Floor,RMZ Millenia Business Park, #143, Dr. M.G.R. Road, Kandanchavady,
Chennai
TAMIL NADU
600096
India |
| Phone |
+91 44 4390 2988 |
| Fax |
+91 44 4359 3492 |
| Email |
v.muppavarapu@iconplc.com |
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Details of Contact Person
Public Query
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| Name |
Ms. Larisa Nagra Singh |
| Designation |
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| Affiliation |
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| Address |
ICON Clinical Research India Pvt Ltd ( CRO)
Sharadha Towers (unit-II)
Bangalore
KARNATAKA
560046
India |
| Phone |
+91 80 4039 4001 |
| Fax |
+91 80 4153 5656 |
| Email |
larisa.nagrasingh@iconplc.com |
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Source of Monetary or Material Support
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| Merck KGaA, Frankfurter Str. 25,0
64293 Darmstadt, Germany
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Primary Sponsor
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| Name |
Merck KGaA, Frankfurter Str. 25,0
64293 Darmstadt, Germany
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Govind Babu |
Kidwai Memorial Institute of Oncology |
Dr. M. M. Mari Gowda Road, ,-560 029
Bangalore
KARNATAKA |
080 ? 26094035
080-6565671
kgblaugh@ymail.com |
| Dr. Sachin V. Almel |
P. D. Hinduja National Hospita |
P. D. Hinduja National Hospita; & Medical Research Centre, Veer Savarkar Marg. Mahim west,-400 016
Mumbai
MAHARASHTRA |
022-24447006
022-24440425
svalmel@yahoo.com |
| Dr. Shyam Aggarwal |
Sir Ganga Ram Hospital |
Rajender Nagar,-110 060
New Delhi
DELHI |
09811075870
011-25861002
drshyam_aggarwal@yahoo.com |
| Dr. Rakesh Jalali |
Tata Memorial Hospital |
Dept. of radiation Oncology,Ground Floor, Main Building, dr. E. Borges Road, Parel-400 012
Mumbai
MAHARASHTRA |
022 ? 2417 7153
022 -24154005
rjalali@tmc.gov.in |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee,Sir Ganga Ram Hospital |
Submittted/Under Review |
| Human Ethics Committee, Tata Memorial Hospital |
Submittted/Under Review |
| Medical Ethics Committee, Kidwai Memorial Institute of Oncology - Submitted for Approval |
Approved |
| National health & Education Society, P D Hinduja National Hospital & Medical Research Centre |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Breast Cancer, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Control Arm - 0.9% sodium chloride & L-BLP25 placebo |
2. Control Arm - All subjects randomized to the control arm will begin the following treatment regimen within four days of randomization:
? 0.9% sodium chloride:
- A single I.V. infusion of 0.9% sodium chloride administered three days before initial dosing of placebo.
? L-BLP25 placebo and hormonal treatment.
- Primary treatment phase: Eight consecutive weekly subcutaneous treatments with L-BLP25 placebo at Weeks 1, 2, 3, 4, 5, 6, 7, and 8 and hormonal treatment
- Maintenance treatment phase: Treatment with L-BLP25 placebo at six-week intervals, beginning at Week 14 and hormonal treatment and continuing until PD is documented or the subject discontinues for any other reason.
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| Intervention |
Investigational Arm - L-BLP25 |
1000µg* of L-BLP25 intended for Subcutaneous administration and hormonal treatment (standard dose).
1. Investigational Arm - All subjects randomized to the investigational arm will begin the following treatment regimen within four days of randomization:
? Cyclophosphamide:
o A single I.V. infusion of 300 mg/m2 of cyclophosphamide administered three days prior to the first L-BLP25 vaccination. The maximum allowable dose of cyclophosphamide is 600 mg.
? L-BLP25 and hormonal treatment:
o Primary treatment phase: Eight consecutive weekly subcutaneous vaccinations with 1000 μg* L-BLP25 at Weeks 1, 2, 3, 4, 5, 6, 7, and 8 and hormonal treatment
o Maintenance treatment phase: Vaccinations with 1000 μg* L-BLP25 at six-week intervals, beginning at Week 14 and hormonal treatment and continuing until PD is documented or the subject discontinues for any other reason.
* calculated as mass of lipopeptide (antigen) |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Postmenopausal women
2. ER+ and/or PgR+, histologically or cytologically confirmed primary carcinoma of the breast
3. Expressing at least one of the following five HLA haplotypes, as centrally assessed by HLA genotyping from whole blood: HLA-A2, -A3, -A11, -B7, or -B35
4. Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone).
5. Measurable disease by RECIST, and inoperable
6. ECOG performance status of 0 or 1
7. Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the protocol
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| ExclusionCriteria |
| Details |
Disease Status
1. PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 12 months of completing such therapy
2.Human epidermal growth factor receptor 2-positive (HER2+) breast cancer
3. 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.)
4. Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies
5. Past or current history of malignant neoplasm other than 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
Pre-therapies
1.Receipt of immunotherapy (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.
2. 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
3. Central nervous system disease or brain metastases, as documented by computed tomography (CT) or magnetic resonance imaging (MRI)
4. Splenectomy
Standard Criteria
1. 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.
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Method of Generating Random Sequence
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Permuted block randomization, variable |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Progression-free survival (PFS) time will be analyzed as the main measure of treatment outcome. PFS time is defined as the duration from randomization to first observation of PD by the independent radiological review or death. |
First assessment (of PFS) after 15 monthsl then on an ongoing basis |
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Secondary Outcome
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| Outcome |
TimePoints |
| Measurement Response Evaluation Criteria in Solid Tumours (RECIST) |
Pre-treatment visit, every 8 weeks thereafter, starting with week 14 during the Maintenance Treatment, and at the End of Study visit. |
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Target Sample Size
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Total Sample Size="909"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Suspended |
| Recruitment Status of Trial (India) |
Suspended |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The purpose of the study is to determine whether the addition of the experimental cancer vaccine Stimuvax to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent or metastatic breast cancer. The study in that will be conducted in four centers in India & approximately 180 sites across Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States.?
- DCGI approval received in India
- Target number of subjects to be enrolled globally is 909.
- Target number of subjects to be enrolled in India is 24
- No subjects recruited in India yet.
- Planned date of recruitement in India - 25 March 2010 |