Tumour Registry Breast Cancer

NCT ID: NCT01351584

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Arbeitskreis Klinische Studien

OTHER

Sponsor Role collaborator

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

Sponsor Role collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Tesch, MD

Role: STUDY_CHAIR

References

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Fietz T, Tesch H, Rauh J, Boller E, Kruggel L, Janicke 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.

Reference Type BACKGROUND
PMID: 28586735 (View on PubMed)

Schroder J, Fietz T, Kohler A, Petersen V, Tesch H, Spring L, Fleitz A, Janicke 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.

Reference Type BACKGROUND
PMID: 28494404 (View on PubMed)

Hurtz HJ, Tesch H, Gohler T, Hutzschenreuter U, Harde J, Kruggel L, Janicke 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.

Reference Type BACKGROUND
PMID: 28677012 (View on PubMed)

Fietz T, Zahn MO, Kohler A, Engel E, Frank M, Kruggel L, Janicke 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.

Reference Type BACKGROUND
PMID: 29030786 (View on PubMed)

Dorfel S, Steffens CC, Meyer D, Tesch H, Kruggel L, Frank M, Janicke 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.

Reference Type BACKGROUND
PMID: 29204847 (View on PubMed)

Marschner N, Trarbach T, Rauh J, Meyer D, Muller-Hagen S, Harde J, Dille S, Kruggel L, Janicke 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.

Reference Type BACKGROUND
PMID: 30868393 (View on PubMed)

Other Identifiers

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Tumorregister Mammakarzinom

Identifier Type: OTHER

Identifier Source: secondary_id

IOM TMK

Identifier Type: -

Identifier Source: org_study_id

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