STRIDE - STimulating Immune Response In aDvanced brEast C... | NCT00925548

ID	Type	Description	Link
2008-005544-17	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational Arm	Experimental	Investigational Arm: Pretreatment (Single Dose): 300 milligrams per square meter (mg/m^2) up to a maximum dose of 600 mg of intravenous cyclophosphamide tecemotide (L-BLP25) plus Hormonal Therapy (Standard Dose)	Biological: Tecemotide (L-BLP25) and Hormonal Treatment Drug: cyclophosphamide
Control Arm	Active Comparator	Control Arm: Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/L) infusion Placebo plus Hormonal Therapy (Standard Dose)	Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment Drug: sodium chloride (NaCl)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tecemotide (L-BLP25) and Hormonal Treatment	Biological	Investigational Arm: Pretreatment (Single Dose) 300 mg/m^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg). Primary treatment phase: Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)* (Week 1 to 8). Maintenance treatment phase: Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD). *calculated as mass of lipopeptide (antigen)

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.	Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Measure	Description	Time Frame
Overall Survival (OS) Time	OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.	Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women as defined in the protocol
Estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, histologically or cytologically confirmed primary carcinoma of the breast
Expressing at least one of the following five human leukocyte antigen (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 Response Evaluation Criteria in Solid Tumors (RECIST), and inoperable
Eastern Cooperative Oncology Group (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
Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

Disease Status

PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 48 months from the initiation of such therapy
Human epidermal growth factor receptor 2-positive (HER2+) breast cancer as defined in the protocol
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 breast cancer (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
Known active Hepatitis B infection or carrier state and/or Hepatitis C infection, known Human Immunodeficiency Virus infection, or any other infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response or could expose her to the likelihood of more and/or severe side effects

Pre-therapies

Receipt of immunotherapy (for example [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 receipt of investigational systemic drugs (including off-label use of approved products) or any kind of systemic treatment (chemotherapy, or immunotherapy), with the exception of hormonal therapy (HT) when given for a period not exceeding 4 weeks (28 days) prior to randomization, for treatment of inoperable, locally advanced, recurrent, or metastatic breast cancer
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)
Medical or psychiatric conditions that would interfere with the ability to provide informed consent, communicate side effects, or comply with protocol requirements
Clinically significant cardiac disease, e.g., cardiac failure of New York Heart Association (NYHA) classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, or myocardial infarction in the previous six months, as confirmed by an electrocardiogram (ECG)
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
Participation in another clinical study within 30 days prior to randomization
Known hypersensitivity to the study drugs
Known alcohol or drug abuse
Legal incapacity or limited legal capacity
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Subject who could be regarded as "vulnerable" according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (e.g., the subject's willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate, plus persons kept in detention; persons in nursing homes; subjects in emergency situations; homeless persons; and nomads)
Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study

Name	Affiliation	Role
Oscar Kashala, MD, PhD, DSc	EMD Serono	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Hickory	North Carolina		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
40443562	Derived	Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

ID	Title	Description
FG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.

Arm/Group Information

ID	Title	Description
BG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
BG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS)

PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.

Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).

Posted

Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Units	Counts
Participants	OG0000 OG0010

Secondary

Overall Survival (OS) Time

OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Percentage of Participants With Objective Tumor Response

Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L

Secondary

Duration of Response

Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Percentage of Participants With Clinical Benefit

Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Time to Progression (TTP)

TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).

Posted

Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Time to Chemotherapy

Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire

FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Baseline, Week 9, 20, 32, 44 and end of trial visit

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

European Questionnaire-5 Dimensions (EQ-5D) Questionnaire

EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Baseline, Week 9, 20, 32, 44 and end of trial visit

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Number of Participant Utilizing Healthcare Resources

Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Randomization up to end of trial visit

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Secondary

Serum Carcinoma Antigen (CA) 15-3 Levels

CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.

Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Posted

Baseline, Week 5, 9, 20, 32, 44 and end of trial visit

ID	Title	Description
OG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
OG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide	Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.			1	11	9	11
EG001	Placebo + Hormonal Therapy + NaCl 9 g/L	Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.			0	5	3	5

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Bradycardia	Cardiac disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Eye swelling	Eye disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Ocular hyperaemia	Eye disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Vision blurred	Eye disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0007 affected11 at risk EG0011 affected5 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected11 at risk EG0011 affected5 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected11 at risk EG0010 affected5 at risk
Constipation	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected11 at risk EG0010 affected5 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected11 at risk EG0010 affected5 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Eructation	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Odynophagia	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Fatigue	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0004 affected11 at risk EG0010 affected5 at risk
Injection site erythema	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected11 at risk EG0010 affected5 at risk
Asthenia	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0011 affected5 at risk
Injection site haematoma	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Injection site induration	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Injection site pain	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Injection site pruritus	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Injection site swelling	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Non-cardiac chest pain	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Oedema peripheral	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected11 at risk EG0010 affected5 at risk
Influenza	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Urinary tract infection	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected11 at risk EG0010 affected5 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected11 at risk EG0010 affected5 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Dizziness	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected11 at risk EG0010 affected5 at risk
Headache	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Hypoaesthesia	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Sinus headache	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Anxiety	Psychiatric disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0011 affected5 at risk
Depression	Psychiatric disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected11 at risk EG0010 affected5 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Hot flush	Vascular disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected11 at risk EG0010 affected5 at risk
Hypertension	Vascular disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Phlebitis	Vascular disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk
Thrombosis	Vascular disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected11 at risk EG0011 affected5 at risk
Chills	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected11 at risk EG0010 affected5 at risk

ID	Term
D001943	Breast Neoplasms
D012008	Recurrence

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds