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

NCT02364492 | Completed Phase 1 DMC

• 1 other identifier: 2014.14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Neoplasms

Keywords

[C04.588.180]

Outcome Measures

Primary Outcomes (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.

  3 weeks after 2 study vaccine injections corresponding to visit number 5.

Study Arms (1)

MAG-Tn3 + AS15

EXPERIMENTAL

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

Interventions

MAG-TN3 + AS15 DRUG

MAG-Tn3 + AS15

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (see below criteria n°3)
• And Non metastatic (M0)
• HER2/neu-negative (Immunohistochemical expression "0-1+", and/or FISH/CISH "non amplified" according to ASCO 2012 criteria)
• First line treatment population with a High-Risk of Relapse as defined by:
• with at least one positive lymph nodes (LN) at primary surgery
• or after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
• Negative hormone receptors: ER- and PR- , (\<10%), i.e "Triple Negative breast cancer"
• 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.
• Patients must be free of any breast cancer recurrence as shown by standard diagnostic tests at the entry into the study.
• Patients should have an expected life expectancy of at least 12 months as evaluated by the investigator at the entry into the study.
• Written informed consent must be obtained prior to any protocol-specific procedures.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Patients must not be pregnant. Non-menopausal women must have a negative pregnancy test prior to enrolment, and must use adequate contraception (1 barrier method) throughout the study.

You may not qualify if:

• Any breast cancer recurrence or metastasis.
• Patients with HER2/neu positive breast carcinoma (IHC score 2+ or 3+ and/or FISH/CISH-amplified).
• Patients with any uncontrolled bleeding disorder including coagulation disorder or thrombocytopenia or prothrombotic disorder.
• 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).
• Patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or other known or unknown allergens.
• Patients with previous splenectomy or radiation to the spleen.
• Patients who have received a major organ graft (including bone-marrow transplantation).
• Patients who require chronic oral treatment (defined as more than 14 days) with immunosuppressive agents including glucocorticosteroïds or other immune-modifying drugs. Use of topical and eye drops containing glucocorticosteroïds is acceptable, as well as inhaled corticosteroids.
• Patients with previous or concomitant malignancies at other sites except effectively treated malignancy that has been in remission for \>5 years and highly likely to have been cured. However patients with non-melanoma skin cancers or carcinoma in situ of the cervix can be included.
• Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• Patient with previous congestive heart failure or difficult-to-control hypertension and any uncontrolled vascular or cardiac disease.
• Patient who has medically documented history of or active major depressive episode, bipolar disorders (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others).
• Patient selects a response of "1,2 or 3" to question 9 on the PHQ-9 question regarding potential for suicidal thought or ideation (independent of the total score of PHQ-9)
• Patient who has \> CTCAE grade 3 anxiety.
• Patients who have received any immunoglobulins and/or blood products within the 3 weeks prior to vaccine injection.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (5)

Centre Léon Bérard

Lyon, France

Location

Institut de Cancérologie de l'OUEST - Centre René Gauducheau

Nantes, 44805, France

Location

Institut Curie

Paris, 75005, France

Location

HEGP

Paris, France

Location

Institut Gustave Roussy (IGR)

Villejuif, 94805, France

Location

Related Publications (1)

• Rosenbaum P, Artaud C, Bay S, Ganneau C, Campone M, Delaloge S, Gourmelon C, Loirat D, Medioni J, Pein F, Sablin MP, Tredan O, Varga A, Leclerc C. The fully synthetic glycopeptide MAG-Tn3 therapeutic vaccine induces tumor-specific cytotoxic antibodies in breast cancer patients. Cancer Immunol Immunother. 2020 May;69(5):703-716. doi: 10.1007/s00262-020-02503-0. Epub 2020 Feb 7.

  PMID: 32034426 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Claude Leclerc

  Institut Pasteur

  STUDY CHAIR

• Mario Campone

  Institut de Cancérologie de l'Ouest (ICO)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: November 11, 2021
• Last Updated: April 1, 2022

Record last verified: 2021-07

Locations

FR (5)