None listed
Conditions
Interventions
Intervention1: Investigational Arm - L-BLP25: 1000µ
g* 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 tr
g* L-BLP25 at Weeks 1, 2, 3, 4, 5, 6, 7, and 8 and hormonal treatment
o Maintenance treatment phase: Vaccinations with 1000 &
g* 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 lipopeptid
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. inf
Sponsors
Merck KGaA, Frankfurter Str. 25,0
64293 Darmstadt, Germany
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: First assessment (of PFS) after 15 monthsl then on an ongoing basis | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement Response Evaluation Criteria in Solid Tumours (RECIST)Timepoint: Pre-treatment visit, every 8 weeks thereafter, starting with week 14 during the Maintenance Treatment, and at the End of Study visit. | — |
Countries
India
Contacts
Public ContactMs. Larisa Nagra Singh
Senior Clinical Research Physician, Medical Affairs
Outcome results
None listed