Breast CancerPhase 3STRIDENCT00925548
STRIDE - STimulating Immune Response In aDvanced brEast Cancer
A Phase 3 study testing Tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide and sodium chloride (NaCl) in people with Breast Cancer, run by EMD Serono at 29 sites in 12 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide and sodium chloride (NaCl)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 29 sitesin 12 countries
- Study dates
- Sep 2009to Aug 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
29 sites in 12 countries.
29 sites in 12 countries
Germany10 sites
Research Site
Chemnitz
Research Site
Darmstadt
Research Site
Frankfurt am Main
Research Site
Hamburg
Research Site
Kiel
Research Site
Lübeck
Research Site
München
Research Site
Rostock
Research Site
Tübingen
Research Site
Wiesbaden
Slovakia4 sites
Research Site
Bratislava
Research Site
Nitra
Research Site
Poprad
Research Site
Trnava
Russia3 sites
Research Site
Obninsk
Research Site
Saint Petersburg
Research Site
Tula
About this study
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
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).
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Tecemotide (L-BLP25) and Hormonal Treatment, Placebo of tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide, sodium chloride (NaCl)
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecemotide (L-BLP25) and Hormonal TreatmentBiological
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)
Placebo of tecemotide (L-BLP25) and Hormonal TreatmentBiological
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).
cyclophosphamideDrug
300 mg/m^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.
sodium chloride (NaCl)Drug
NaCl 9 g/L infusion
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment; Drug: sodium chloride (NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Week 5, 9, 20, 32, 44 and end of trial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: See termination reason in the below Purpose statement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Kashala, MD, PhD, DSc, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925548
- Sponsor's protocol ID
- EMR 200038-010
- Other IDs
- 2008-005544-17, 2008
- Acronym
- STRIDE
- Status last verified
- Jul 2014
- First submitted
- 17 Jun 2009
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 40443562
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00925548
- Acronym / sponsor ID
- STRIDE / EMR 200038-010
- Conditions
- Breast Cancer
- Keywords
- Phase III trial, randomized, cancer vaccine, MUC1, BLP25, advanced breast cancer, postmenopausal breast cancer, immunotherapy of breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in the below Purpose statement
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Biological: Tecemotide (L-BLP25) and Hormonal Treatment, Drug: cyclophosphamideInvestigational 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) |
| Control Arm | Active comparator | Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment, Drug: sodium chloride (NaCl)Control Arm: * Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/L) infusion * Placebo plus Hormonal Therapy (Standard Dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecemotide (L-BLP25) and Hormonal TreatmentInvestigational 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) | Biological | Investigational Arm |
| Placebo of tecemotide (L-BLP25) and Hormonal TreatmentControl 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). | Biological | Control Arm |
| cyclophosphamide300 mg/m^2 (to a maximum of 600 mg) of intravenous cyclophosphamide. | Drug | Investigational Arm |
| sodium chloride (NaCl)NaCl 9 g/L infusion | Drug | Control Arm |
Primary outcome
Progression-Free Survival (PFS)
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
PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.
10 secondary outcomes
Overall Survival (OS) Time
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
Time frame: Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010
Duration of Response
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
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)
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 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
Time frame: Baseline, Week 9, 20, 32, 44 and end of trial visit
European Questionnaire-5 Dimensions (EQ-5D) Questionnaire
Time frame: Baseline, Week 9, 20, 32, 44 and end of trial visit
Number of Participant Utilizing Healthcare Resources
Time frame: Randomization up to end of trial visit
Serum Carcinoma Antigen (CA) 15-3 Levels
Time frame: Baseline, Week 5, 9, 20, 32, 44 and end of trial visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40443562Gorodetska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Kashala, MD, PhD, DSc study director
EMD Serono
29 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide and sodium chloride (NaCl) in people with Breast Cancer, run by EMD Serono at 29 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Slovakia, Russia, Austria, Czechia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00925548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.