Breast CancerTMKNCT01351584
Tumour Registry Breast Cancer
An observational study of Breast Cancer, run by iOMEDICO AG.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Dec 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients undergoing antineoplastic or antihormonal therapy.
Who may be able to join
- Breast cancer
- 18 years and older
- Antineoplastic or antihormonal treatment
Who cannot join
- No breast cancer
- Below 18 years
- No antineoplastic or antihormonal treatment
About this study
Official title: Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany
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.
Read the detailed 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).
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Advanced Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Drug Therapy, Nutrition Assessment, Physical Activity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of Antineoplastic Treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startFeb 2007
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbeitskreis Klinische Studien, Arbeitsgemeinschaft fur Internistische Onkologie
- Responsible party
- Sponsor
- Investigators
- Hans Tesch, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351584
- Sponsor's protocol ID
- IOM TMK
- Other IDs
- Tumorregister Mammakarzinom
- Acronym
- TMK
- Status last verified
- Aug 2025
- First submitted
- 9 May 2011
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28586735Schroder 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.
PubMed 28494404Hurtz 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.
PubMed 28677012Fietz 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.
PubMed 29030786Dorfel 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.
PubMed 29204847Marschner 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.
PubMed 30868393
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany
- ClinicalTrials.gov ID
- NCT01351584
- Acronym / sponsor ID
- TMK / IOM TMK
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Advanced Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Arbeitskreis Klinische Studien, Arbeitsgemeinschaft fur Internistische Onkologie
- Study start
- Feb 2007 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients undergoing antineoplastic or antihormonal therapy.
Key inclusion criteria (3 listed)
- Breast cancer
- 18 years and older
- Antineoplastic or antihormonal treatment
Key exclusion criteria (3 listed)
- No breast cancer
- Below 18 years
- No antineoplastic or antihormonal treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Course of Antineoplastic Treatment
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 28586735Fietz 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.
- Background: PubMed 28494404Schroder 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.
- Background: PubMed 28677012Hurtz 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.
- Background: PubMed 29030786Fietz 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.
- Background: PubMed 29204847Dorfel 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.
- Background: PubMed 30868393Marschner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Tesch, MD study chair
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by iOMEDICO AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of Antineoplastic Treatment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351584, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.