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:
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
  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:

  • Pretreatment (Single Dose): 300 mg/m2 of IV cyclophosphamide
  • L-BLP25 plus Hormonal Therapy (Standard Dose)
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)

Drug: cyclophosphamide
300 mg/m2 of IV cyclophosphamide
Active Comparator: Control Arm:

Control Arm:

  • Pretreatment (Single Dose): 0.9% sodium chloride infusion
  • Placebo plus Hormonal Therapy (Standard Dose)
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)

Drug: sodium chloride
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925548

  Show 29 Study Locations
Sponsors 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 July 22, 2014