JOURNAL ONKOLOGIE – STUDIE

Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT03961880

Studienbeginn:
März 2019

Letztes Update:
28.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms, Recurrence

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Kontakt

Andreas Hartkopf, MD
Kontakt:
Phone: 4970712982211
E-Mail: andreas.hartkopf@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department for Women's Health
72086 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Brucker Sara, MD» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry

that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant

therapy recommendations in the clinical routine. Additionally, the proportion of patients

with low, intermediate and high RS in predefined clinical subgroups will be determined. To

evaluate the impact of the RS on tumor cell dissemination, these subgroups also include

DTC-negative versus DTC-positive patients.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- women ≥ 18 years of age

- histologically proven unilateral primary non-metastatic invasive breast cancer

- ER-/ or PR- positive and HER2-negative

- N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically.

- surgery or planed surgery at the Department of women's health, Tuebingen

- written informed consent into IRMA

Exclusion Criteria:

- ER-negative

- HER2-positive

- > 3 involved lymph-nodes

- bilateral breast cancer

- preexisting cancer disease within the last 10 years

- preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or

contralateral breast cancer is not regarded as an exclusion criteria)

- primary systemic therapy

- locally advanced, inoperable or metastatic breast cancer

- pregnant or lactating patients

- inadequate general condition (not fit for chemotherapy)

Studien-Rationale

Primary outcome:

1. Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation (Time Frame - 1 year):
The Recurrence Score is a continuous score that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only). Oncotype DX test results assign a Recurrence Score - a number between 0 and 100 - to the early-stage breast cancer or DCIS. Recurrence Score lower than 18: The cancer has a low risk of recurrence. The benefit of chemotherapy is likely to be small and will not outweigh the risks of side effects. Recurrence Score of 18 up to and including 30: The cancer has an intermediate risk of recurrence. It's unclear whether the benefits of chemotherapy outweigh the risks of side effects. Recurrence Score greater than or equal to 31: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.

Secondary outcome:

1. Evaluation of the association of the RS with tumor cell dissemination into bone marrow (Time Frame - 1 year):
Bone marrow sampling is performed during primary surgery as part of the clinical routine. The presence of disseminated tumor cells (DTC status) is evaluated by immunostaining.

2. Correlation of the RS with age (Time Frame - 1 year):
age in years

3. Correlation of the RS with tumor nodal status (Time Frame - 1 year)

4. Correlation of the RS with tumor grading (Time Frame - 1 year)

5. Correlation of the RS with proliferation marker Ki-67 (Time Frame - 1 year)

Quelle: ClinicalTrials.gov

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