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COMPLETEDPHASE1

Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer

A Multicenter, Open-label Phase I/II Trial of the Safety and Efficacy of the dHER2 Recombinant Protein Combined With Immunological Adjuvant AS15 in Patients With Metastatic Breast Cancer Overexpressing HER2/Neu

NCT00140738•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.

Detailed Description

This Phase I/II study will be conducted according to a multicenter, open-label design. At least 20 patients will receive the vaccine as first-line and at least 20 as second-line treatment. The treatment will comprise a maximum of 18 injections of dHER2 vaccine. Follow-up phase: This will commence with the end-of-treatment examination, followed by examinations three months, six months and twelve months after the last study vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female.
•At least 18 years of age.
•Written informed consent to participate in the study.
•Diagnosis of advanced breast cancer. Furthermore, for patients being considered for second-line study treatment only: The patient has received a first-line chemotherapy together with Herceptin - or Herceptin alone - for her metastatic breast disease meeting all of the following conditions:
•i) For patients who have received a first-line chemotherapy together with Herceptin:
•The administration of chemotherapeutic agent(s) has been stopped for at least 3 months, or will have been stopped for at least 3 months by the time of the first study vaccination, and
•The administration of Herceptin alone was maintained after chemotherapy.
•ii) The last dose of Herceptin was given not less than 3 weeks before the study vaccination.
•iii) The patient will not be given Herceptin during the trial.
•A tumor lesion from the patient biopsied before or during screening, shows either i) overexpression of the HER2 protein, as determined by IHC (result: IHC 3+), or ii) amplification of the HER2 gene as determined by FISH (at least 4-fold, i.e., at least 8 copies).
+12 more criteria

Exclusion Criteria

•For patients being considered for first-line study treatment only:
•Received any chemotherapy for metastatic breast disease.
•Received \>300 mg/m2 doxorubicin (cumulative dose) or \>600 mg/m2 epirubicin (cumulative dose).
•Although hormone therapy as a first-line therapy for metastatic disease is accepted, it must NOT have been started or modified (in nature or dosage) within the 12 weeks before the first study vaccination, and NO such change during the study period may be anticipated.
•Treatment with bisphosphonate UNLESS the bisphosphonate treatment was initiated more than 3 months before first study vaccination.
•Received any investigational or non-registered drug or vaccine other than the study vaccine within the 30 days preceding the first dose of study vaccine, or plans to receive such a drug during the study period.
•For patients being considered for first-line study treatment, any of the following will result in exclusion of the patient:
•1. Any organ other than skin, lymph nodes, bone and lung is affected by the metastatic disease.
•2. If the lung is affected: \>3 lung lesions have been detected.
•3. If the lung is affected: Any lesion measures 30 mm or more (longest diameter).
+19 more criteria

Locations (14)

GSK Investigational Site

Charleroi, Belgium

GSK Investigational Site

Hasselt, Belgium

GSK Investigational Site

Ottignies, Belgium

GSK Investigational Site

Bogotá, Colombia

GSK Investigational Site

Lyon, France

GSK Investigational Site

Montpellier, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Saint-Cloud, France

GSK Investigational Site

Saint-Herblain, France

GSK Investigational Site

Toulouse, France

Key Dates

Start Date

March 10, 2005

Primary Completion Date

September 29, 2008

Completion Date

September 29, 2009

Last Updated

December 27, 2019

Enrollment

ACTUAL participants

Conditions

Neoplasms, Breast

Interventions

GSK Biologicals' 719125

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients