Re‑Examination of Tumor Material and Re‑Evaluation of Patient Data From Patients Treated With Neo‑adjuvant Therapy

Trial status:Study Complete
Trial ID:
MammaTyper_1.neo-adjuvant st.
NCT ID:
NCT02449993
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech Diagnostics GmbH
Study Complete

Trial Details

This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with MammaTyper™.

According to the determined values for the individual parameters at least 4 subtypes can be distinguished to date

  • Luminal A-type
  • Luminal B-type
  • HER2-type
  • Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with Immunohistochemical methods will be evaluated.

As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall survival (OS) will be reevaluated according to the new subtyping.

Medical Condition
  • Breast Cancer
    • Trial Drug
    N/A
    Phase
    N/A
    Type
    Observational
    Estimated Enrolment
    101
    Estimated Trial Date
    Jun 2014 - Sep 2014

    Trial Participant Requirements

    Age
    18 - 70 Years
    Sex
    Female
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    • Women aged 18-70 years with histologically confirmed primary invasive breast cancer stages T2-T4/N0-N2/M0 with a tumor size of ≥ 2 cm as measured by ultrasound
    • The patient provides a written informed consent for analysis of tumor material

      • Exclusion Criteria:

    • Prior anticancer therapy with an anthracycline or other prior antitumor therapy for breast cancer
    • Inflammatory or exulcerating breast cancer
    • A second primary malignancy [except carcinoma in situ (CIS) of the cervix or adequately treated nonmelanoma skin cancer] unless diagnosed and treated ≥ 5 years ago with no evidence of recurrence
    • Any serious concomitant systemic disorder

    Trial Locations

    No locations found.