A Phase 3 interventional study of Tecemotide (L-BLP25) and Hormonal Treatment and Placebo of tecemotide (L-BLP25) and Hormonal Treatment in Breast Cancer, sponsored by EMD Serono. Terminated at 29 sites in 12 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-24.
Sponsored by EMD Serono · Phase 3, Interventional, and Treatment
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
The purpose of the study is to determine whether the addition of the experimental mucinous glycoprotein 1 (MUC1) antigen-specific cancer immunotherapy tecemotide (L-BLP25) to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent or metastatic breast cancer.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 16 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Disease Status
Pre-therapies
Prior use of bisphosphonates or concurrent use while on study treatment is allowed
Physiological Function
Standard Criteria
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: * 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)
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)
Control Arm: Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide. Primary treatment phase: Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8). Maintenance treatment phase: Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).
300 mg/m\^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.
NaCl 9 g/L infusion
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 frame: 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
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 frame: 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
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.
Time frame: Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010
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.
Time frame: 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
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.
Time frame: Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010
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).
Time frame: 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
Time to Chemotherapy
Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.
Time frame: 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
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.
Time frame: Baseline, Week 9, 20, 32, 44 and end of trial visit
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.
Time frame: Baseline, Week 9, 20, 32, 44 and end of trial visit
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).
Time frame: Randomization up to end of trial visit
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.
Time frame: Baseline, Week 5, 9, 20, 32, 44 and end of trial visit
| Milestone | Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide | Placebo + Hormonal Therapy + NaCl 9 g/L |
|---|---|---|
| Started | 11 | 5 |
| Completed | 1 | 0 |
| Not completed | 10 | 5 |
| Withdrew: Discontinuation of trial by sponsor | 10 | 5 |
PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).
No measurements were reported for this outcome.
Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.
No measurements were reported for this outcome.
Collected over Baseline (First treatment dose) up to end of trial i.e. 27 Aug 2010. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide | — | 1/11 (9.1%) | 9/11 (81.8%) |
| Placebo + Hormonal Therapy + NaCl 9 g/L | — | 0/5 (0%) | 3/5 (60%) |
| Event | Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide | Placebo + Hormonal Therapy + NaCl 9 g/L |
|---|---|---|
| Intestinal obstructionGastrointestinal disorders | 1/11 | 0/5 |
| Event | Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide | Placebo + Hormonal Therapy + NaCl 9 g/L |
|---|---|---|
| NauseaGastrointestinal disorders | 7/11 | 1/5 |
| FatigueGeneral disorders | 4/11 | 0/5 |
| VomitingGastrointestinal disorders | 3/11 | 1/5 |
| Abdominal painGastrointestinal disorders | 3/11 | 0/5 |
| ConstipationGastrointestinal disorders | 3/11 | 0/5 |
| Injection site erythemaGeneral disorders | 3/11 | 0/5 |
| NasopharyngitisInfections and infestations | 3/11 | 0/5 |
| Neck painMusculoskeletal and connective tissue disorders | 3/11 | 0/5 |
| Eye swellingEye disorders | 0/11 | 1/5 |
| Ocular hyperaemiaEye disorders | 0/11 | 1/5 |
Safety population included all participants who received at least one dose of any study treatment (L-BLP25, placebo, cyclophosphamide, saline, or any of the three hormonal therapies).
| Age, Customized(participants) | Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide | Placebo + Hormonal Therapy + NaCl 9 g/L | Total |
|---|---|---|---|
| Less than (<) 65 years | 5 | 2 | 7 |
| Greater than or equal to (>=) 65 years | 6 | 3 | 9 |
| Sex: Female, Male(Participants) | Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide | Placebo + Hormonal Therapy + NaCl 9 g/L | Total |
|---|---|---|---|
| Female | 11 | 5 | 16 |
| Male | 0 | 0 | 0 |
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
EMD Serono