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NCT01351584 Clinical Trial

Tumour Registry Breast Cancer

Breast Cancer Clinical Trial

— TMK  

Official title:
Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01351584
Other study ID # IOM TMK
Secondary ID Tumorregister Ma
Status Completed
Phase
First received
Last updated
Start date February 2007
Est. completion date December 2021

Study information
Verified date February 2022
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

Description:

The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. The impact of nutrition (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

Recruitment information / eligibility
Status Completed
Enrollment 4500
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Breast cancer - 18 years and older - Antineoplastic or antihormonal treatment Exclusion Criteria: - No breast cancer - Below 18 years - No antineoplastic or antihormonal treatment

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
iOMEDICO AG Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien

References & Publications (6)

Dörfel S, Steffens CC, Meyer D, Tesch H, Kruggel L, Frank M, Jänicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Adjuvant chemotherapeutic treatment of 1650 patients with early breast cancer in routine care in Germany: data from the prospective TMK cohort study. Breast Cancer. 2018 May;25(3):275-283. doi: 10.1007/s12282-017-0823-7. Epub 2017 Dec 4. — View Citation

Fietz T, Tesch H, Rauh J, Boller E, Kruggel L, Jänicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Palliative systemic therapy and overall survival of 1,395 patients with advanced breast cancer - Results from the prospective German TMK cohort study. Breast. 2017 Aug;34:122-130. doi: 10.1016/j.breast.2017.05.014. Epub 2017 Jun 3. — View Citation

Fietz T, Zahn MO, Köhler A, Engel E, Frank M, Kruggel L, Jänicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Routine treatment and outcome of breast cancer in younger versus elderly patients: results from the SENORA project of the prospective German TMK cohort study. Breast Cancer Res Treat. 2018 Jan;167(2):567-578. doi: 10.1007/s10549-017-4534-8. Epub 2017 Oct 13. — View Citation

Hurtz HJ, Tesch H, Göhler T, Hutzschenreuter U, Harde J, Kruggel L, Jänicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Persistent impairments 3 years after (neo)adjuvant chemotherapy for breast cancer: results from the MaTox project. Breast Cancer Res Treat. 2017 Oct;165(3):721-731. doi: 10.1007/s10549-017-4365-7. Epub 2017 Jul 5. — View Citation

Marschner N, Trarbach T, Rauh J, Meyer D, Müller-Hagen S, Harde J, Dille S, Kruggel L, Jänicke M; TMK-Group (Tumour Registry Breast Cancer). Quality of life in pre- and postmenopausal patients with early breast cancer: a comprehensive analysis from the prospective MaLife project. Breast Cancer Res Treat. 2019 Jun;175(3):701-712. doi: 10.1007/s10549-019-05197-w. Epub 2019 Mar 13. — View Citation

Schröder J, Fietz T, Köhler A, Petersen V, Tesch H, Spring L, Fleitz A, Jänicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Treatment and pattern of bone metastases in 1094 patients with advanced breast cancer - Results from the prospective German Tumour Registry Breast Cancer cohort study. Eur J Cancer. 2017 Jul;79:139-148. doi: 10.1016/j.ejca.2017.03.031. Epub 2017 May 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Course of Antineoplastic Treatment 5 years
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