Last updated on January 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: Between 40 - 70 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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