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

Phase 3

Suspended

Conditions: Breast Cancer

Registration Number: CTRI/2009/091/000660

Lead Sponsor: Merck KGaA, Frankfurter Str. 25,064293 Darmstadt, Germany

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 909

Inclusion Criteria

1.Postmenopausal women2.
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 -B354.
Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone).
Measurable disease by RECIST, and inoperable 6.
ECOG performance status of 0 or 17.
Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the protocol.

Exclusion Criteria

Disease Status1.
PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 12 months of completing such therapy2.Human epidermal growth factor receptor 2-positive (HER2+) breast cancer3.
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 immunodeficiencies5.
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 yearsPre-therapies1.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 Function3.
Central nervous system disease or brain metastases, as documented by computed tomography (CT) or magnetic resonance imaging (MRI)4.
SplenectomyStandard Criteria1.
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.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4): Kidwai Memorial Institute of Oncology
🇮🇳
Bangalore, KARNATAKA, India
P. D. Hinduja National Hospita
🇮🇳
Mumbai, MAHARASHTRA, India
Sir Ganga Ram Hospital
🇮🇳
Delhi, DELHI, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, KARNATAKA, India
Dr. Govind Babu
Principal investigator
kgblaugh@ymail.com