A Study of Stimuvax® in Combination With Hormonal Treatment Versus Hormonal Treatment Alone for First-line Therapy of Endocrine-sensitive Advanced Breast Cancer (STRIDE)
This study has been terminated.
(See termination reason in the below Purpose statement)
Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00925548
First received: June 17, 2009
Last updated: September 19, 2011
Last verified: September 2011
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Purpose
Following the clinical hold, EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: Stimuvax (L-BLP 25 or BLP25 liposome vaccine) and Hormonal Treatment Biological: Placebo of Stimuvax (L-BLP 25 or BLP25 liposome vaccine) and Hormonal Treatment Drug: cyclophosphamide Drug: sodium chloride |
Phase 3 |
| 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 |
| 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 |
Resource links provided by NLM:
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- Progression-Free Survival (PFS) time will be analyzed as the main measure of treatment outcome. PFS time is defined as the the duration from randomization to first observation of PD by the independent radiologic review or death. [ Time Frame: first assessment (of PFS) after 15 month; then on an ongoing basis ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measurement Response Evaluation Criteria in Solid Tumours (RECIST) [ Time Frame: Pre-Treatment Visit, every 8 weeks thereafter, starting with week 14 during the Maintenance Treatment, and at the End of Study visit. ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | June 2009 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational Arm
Investigational Arm:
|
Biological: Stimuvax (L-BLP 25 or BLP25 liposome vaccine) and Hormonal Treatment
Investigational Arm: Pretreatment (Single Dose) 300 mg/m2 of IV cyclophosphamide in investigational arm Primary treatment phase: Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with 1000 µg* L-BLP25 (week 1 to 8) Maintenance treatment phase: Hormonal treatment plus vaccinations with 1000 µg* L-BLP25 at six-week intervals beginning at week 14 and continued until Progressive Disease (PD) *calculated as mass of lipopeptide (antigen) 300 mg/m2 of IV cyclophosphamide
|
|
Active Comparator: Control Arm:
Control Arm:
|
Biological: Placebo of Stimuvax (L-BLP 25 or BLP25 liposome vaccine) and Hormonal Treatment
Control Arm: Pretreatment (Single Dose) 0.9% NaCl infusion as placebo Primary treatment phase: Hormonal therapy plus 8 consecutive weekly subcutaneous vaccinations with Placebo (week 1 to 8) Maintenance treatment phase: Hormonal therapy plus Vaccinations with Placebo at six-week intervals beginning at week 14 and continued until Progressive Disease (PD) 0.9% sodium chloride infusion
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal women
- ER+ and/or PgR+, histologically or cytologically confirmed primary carcinoma of the breast
- 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
- Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone).
- Measurable disease by RECIST, and inoperable
- 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
Exclusion Criteria:
Disease Status
- PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 12 months of completing such therapy
- Human epidermal growth factor receptor 2-positive (HER2+) breast cancer
- 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 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
- 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.
- 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)
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925548
Show 29 Study Locations
Show 29 Study LocationsSponsors and Collaborators
EMD Serono
Investigators
| Study Director: | Oscar Kashala, MD, PhD, DSc | EMD Serono |
More Information
No publications provided
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00925548 History of Changes |
| Other Study ID Numbers: | EMR 200038-010 |
| Study First Received: | June 17, 2009 |
| Last Updated: | September 19, 2011 |
| 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 |
Keywords provided by EMD Serono:
|
Phase III trial randomized cancer vaccine MUC1 BLP25 |
advanced breast cancer postmenopausal breast cancer immunotherapy of breast cancer Inoperable locally advanced, recurrent, or metastatic endocrine-sensitive Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013