A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained
      following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses
      of 30 µg, 100 µg or 300 µg IM every three weeks.
    

Detailed description: 
      This study is a three dose level open-label, non-randomized, dose-escalation study Phase I of
      the safety of the vaccine candidate MAG-Tn3 + AS15 administered to patients with HER2
      negative, high-risk localized breast cancer in remission.

      A maximum of 30 patients will be included in the study:

        -  3 or 6 patients in the 1st dose level (30 µg)

        -  6 or 12 patients in the 2nd dose level (100 µg)

        -  6 or 12 patients in the 3rd dose level (300 µg) The clinical study phase I is composed
           of a vaccination period of about 4 months (16 weeks) and a follow-up period of 36 months
           (3 years).

      Each patient will receive one of the three escalating doses of MAG-Tn3 in combination with a
      fixed dose of AS15 adjuvant.

      The subject will receive 6 vaccine injections, administered by intramuscular injection with a
      3-weeks interval between injections. Each patient will be followed 36 months after the last
      injection. The follow-up period is composed of a short-term follow-up period of 6 months and
      a long-term follow-up period of 30 months.

      A total of 20 visits will be required for each patient. Clinical data and blood samples will
      be collected for analysis for each patient.

      Clinical study data will be recorded for each patient on source documentation and then
      entered on electronic CRFs (eCRFs) using a proprietary Electronic Data Capture (EDC) Clinical
      Data Base Software System. The eCRF data are to be entered by site personnel trained in EDC
      data entry.

      A monitor will visit the site regularly to check the completeness of patient records, the
      accuracy of entries on the e-CRFs, the adherence to the protocol and to Good Clinical
      Practice, the progress of enrollment, and to ensure that study drug is being stored,
      dispensed, and accounted for according to specifications.

      Institut Pasteur or designated CRO will conduct data management. Data entered into EDC will
      be housed in a central database. Changes will be tracked to provide an audit trail.
      Interactive data checks will be carried out as applicable during the data entry process.
      Additional data checks are programmed to identify errors in the SAS datasets. Applicable
      queries based on the SAS datasets will be added to EDC for resolution by data management
      personnel. At the conclusion of the study, when all data have been entered and source
      document verified, with no outstanding queries remaining, the Investigator of each site will
      be required to electronically sign each patient's casebook to confirm that the data for each
      patient are complete and accurate and consistent with the patient's source documents. The
      data will then be locked to prevent further editing.

      Concomitant medications entered into the database will be coded using the WHO Drug Reference
      List, which employs the Anatomical Therapeutic Chemical classification system. Medical
      history/current medical conditions and adverse events terminology will be coded using the
      Medical dictionary for regulatory activities.The newest version of the dictionary at data
      base lock will be used.
    

Intervention name(s): MAG-TN3 + AS15
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: [C04.588.180]