STRIDE - STimulating Immune Response In aDvanced brEast Cancer

NCT00925548 | Terminated Phase 3 Results DMC

• 2 other identifiers: EMR 200038-0102008-005544-17
• Study Type: interventional
• Target: 16
• Locations: 11 countries
• Sites: 27

Brief 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).

Conditions

Breast Cancer

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Overall Survival (OS) Time

  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

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

• Duration of Response

  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

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

• Time to Progression (TTP)

  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

Study Arms (2)

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

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)

Investigational Arm

Placebo of tecemotide (L-BLP25) and Hormonal Treatment BIOLOGICAL

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).

Control Arm

cyclophosphamide DRUG

300 mg/m\^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.

Investigational Arm

sodium chloride (NaCl) DRUG

NaCl 9 g/L infusion

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (29)

Research Site

Hickory, North Carolina, United States

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Research Site

Bedford Park, SA, Australia

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Innsbruck, Austria

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Salzburg, Austria

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Leuven, Belgium

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Pardubice, Czechia

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Prague, Czechia

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Chemnitz, Germany

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Darmstadt, Germany

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Frankfurt am Main, Germany

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Hamburg, Germany

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Kiel, Germany

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Lübeck, Germany

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München, Germany

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Rostock, Germany

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Tübingen, Germany

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Wiesbaden, Germany

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Beer Yaakov, Israel

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Opole, Poland

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Obninsk, Russia

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Saint Petersburg, Russia

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Tula, Russia

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Bratislava, Slovakia

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Nitra, Slovakia

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Poprad, Slovakia

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Trnava, Slovakia

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Johannesburg, South Africa

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Gyeonggi-do, South Korea

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Seoul, South Korea

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Related Publications (1)

• 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.

  PMID: 40443562 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Interventions

L-BLP25; Cyclophosphamide; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Oscar Kashala, MD, PhD, DSc

  EMD Serono

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 22, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 24, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-07

Locations

AU (1); PL (1); RU (3); SL (4); US (1); KR (2); BE (1); CZ (2); IL (1); ZA (1); DE (10)