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

Breast Cancer Female Clinical Trial

Official title:

Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961880
• Other study ID #: IRMA
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: Andreas Hartkopf, MD
• Phone: 4970712982211
• Email: andreas.hartkopf[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Recurrence

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tübingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation	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.	1 year
Secondary	Evaluation of the association of the RS with tumor cell dissemination into bone marrow	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.	1 year
Secondary	Correlation of the RS with age	age in years	1 year
Secondary	Correlation of the RS with tumor nodal status		1 year
Secondary	Correlation of the RS with tumor grading		1 year
Secondary	Correlation of the RS with proliferation marker Ki-67		1 year