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A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse (MAGTRIVACSEIN)

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ClinicalTrials.gov Identifier: NCT02364492
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: MAG-TN3 + AS15 Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label First-in-Human Adjuvant Phase I Study of a Synthetic Multiple Antigenic Glycopeptide Displaying a Tri Tn Glycotop (MAG-Tn3) Plus AS15, as a Therapeutic Vaccine Candidate in Patients With Non Metastatic, HER2 Negative Localized Breast Cancer at High-Risk of Relapse
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: MAG-Tn3 + AS15

3 escalating doses of MAG-Tn3 in combination with a fixed dose of AS15 adjuvant.

For each dose patient will receive 6 injections at 3 interval weeks.

Drug: MAG-TN3 + AS15



Primary Outcome Measures :
  1. To assess the number of patient(s) presenting dose-limiting toxicities (DLTs) from the first vaccine injection in the first patient of the dose cohort till 3 weeks after the second vaccine injection of the last patient of the dose cohort. [ Time Frame: 3 weeks after 2 study vaccine injections corresponding to visit number 5. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must have a diagnosis of epithelial breast carcinoma which is, according to TNM classification:

    • Any T
    • With Positive (N+) or Negative (N-) Lymph-Node depending on the patient profile
    • And Non metastatic (M0)
  2. HER2/neu-negative (Immunohistochemical expression "0-1+", and/or FISH/CISH "non amplified" according to ASCO 2012 criteria)
  3. First line treatment population with a High-Risk of Relapse as defined by:

    • with at least 4 positive lymph nodes (LN) at primary surgery, or at least one positive lymph node >pN1mi after completion of 6-8 cycles of anthracyclines/taxanes-based neoadjuvant chemotherapy
    • Or, negative hormone receptors: ER- and PR- , (<10%), i.e "Triple Negative breast cancer" With at least one positive lymph node >pN1mi or negative lymph node if a pathological complete remission was not achieved (persistence of invasive carcinoma) after completion of 6-8 cycles of anthracyclines/taxanes-based neoadjuvant chemotherapy
  4. Patients must have completed all their local and regional treatments including adequate surgery and radiation therapy, and at least 6 cycles of chemotherapy (neoadjuvant and/or adjuvant) according to institutional and national standards.
  5. The time interval between the end of all the first line standard treatment (completion of surgery, chemotherapy and radiation therapy) should be at least 3 months and within a maximum of 18 months before inclusion in the study.

Exclusion Criteria:

  1. Any breast cancer recurrence or metastasis.
  2. Patients with HER2/neu positive breast carcinoma (IHC score 2+ or 3+ and/or FISH/CISH-amplified).
  3. Patients with any uncontrolled bleeding disorder including coagulation disorder or thrombocytopenia or prothrombotic disorder.
  4. Patients with a personal history of autoimmune disease (including but not limited to multiple sclerosis, lupus, rheumatoid polyarthritis, inflammatory bowel diseases, Graves' disease and Hashimoto's disease).
  5. Patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or other known or unknown allergens.
  6. Patients who have received any commercial vaccine within one month before the first dose of study vaccine or are planned to receive any vaccine till 3 weeks after the 6th vaccine injection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364492


Contacts
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Contact: Cécile Artaud 144389241 ext 33 cecile.artaud@pasteur.fr

Locations
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France
Institut de Cancérologie de l'OUEST - Centre René Gauducheau Recruiting
Nantes, France, 44805
Contact: Mario Campone         
Institut Curie Recruiting
Paris, France, 75005
Contact: Marie-Paule Sablin         
Institut Gustave Roussy (IGR) Recruiting
Villejuif, France, 94805
Contact: Suzette Delaloge         
Sponsors and Collaborators
Institut Pasteur
Investigators
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Study Chair: Claude Leclerc Institut Pasteur
Principal Investigator: Mario Campone Institut de Cancérologie de l'Ouest (ICO)

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT02364492     History of Changes
Other Study ID Numbers: 2014.14
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: May 2017
Keywords provided by Institut Pasteur:
[C04.588.180]
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs