Trial document




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  DRKS00007183

Trial Description

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Title

MARTA- Non-interventional observational study to document the efficacy and tolerability of taxanes (Docetaxel, Paclitaxel) in treatment against operable, nodal-positive and locally advanced metastatic mamma carzinoma

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Trial Acronym

MARTA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this non-interventional study, therapy of patients with early metastatic mamma carcinoma is going to be documented, where treatment with docetaxel axios or axitaxel is indicated according to SPC. Contraindications and special warnings and precautions for the treatment with docetaxel or acitaxel SPC should be followed. All eligible patients should be included without any pre-selection in order to get a realistic picture of the practice routine.

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Brief Summary in Scientific Language

The object of investigation of this non-interventional study (NIS) MARTA is to document the efficacy and tolerability of docetaxel axios (active agent: Docetaxel) or axitaxel whilst taking into account the patients’ general health status and to reflect the reality in daily practice routine. The aim of this non-interventional trial is, in accordance with § 67 paragraph 6 of the AMG, to collect data which can be analyzed in terms of use, efficacy and safety (AEs,SAEs) in various therapy regimens against operable, nodal-positive and locally advanced metastatic mamma carcinoma.

Inclusion of patients in this NIS must not have influence on the doctors’ decisions regarding diagnostics and therapy plan during and after treatment.

Docetaxel and paclitaxel are cytotostatics that are indicated for the treatment of breast cancer. They can be used as monotherapy or in combination with other medicines.

The use of docetaxel axios or axitaxel will be assessed especially against the background of the therapy regimen and with regard to the Karnofsky-Index. For the efficacy assessment response parameters and clinical symptoms are relevant, whereas for risk analysis the frequencies of hematological and non-hematological AEs as well as changes regarding the general health status will be used.

Moreover, in particular, the occurrence of neutropenia, which is reported in literature with sometimes more than 30 percent will be documented under real conditions.

The aim is to focus on the following issues and thereby to contribute to scientific knowledge:

1- What dosages and regimes with taxanes (docetaxel axios, axitaxel) used in the daily routine
2- What reasons lead to treatment interruptions and / or withdrawals from treatment?
3- What is the actual risk of neutropenia and other adverse drug reactions among taxanes (docetaxel axios, axitaxel) really?
4- To what extent can a supportive or prophylactic treatment of neutropenia,
bone metastases, anemia and thrombocytopenia have influence on patients’ quality of life.
5- What influence before, during and after infusion has cooling of extremities on incidence of nail toxicity and neurotoxicity?
6- How do the patients consider their quality of life before, at the end of treatment and at follow-up visits by employing standardized quality of life questionnaires (EORTC QLQ-C30 and -BR23)?
7- Are there adverse drug reactions under therpy with docetaxel axios or axitaxel which were not observed so far?
The NIS should be carried out at oncologists, oncology gynecologist and outpatient clinics with an enrollment goal of up to 600 patients.

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Organizational Data

  •   DRKS00007183
  •   2014/11/06
  •   2014/11/03
  •   no
  •   Approved
  •   Bo/21/2014, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  •   U1111-1163-7429 
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   D70 -  Agranulocytosis
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Interventions/Observational Groups

  •   Efficacy and safety profile of docetaxel axios, axitaxel will be documented under routine practice conditions in patients where treatment with docetaxel axios, axitaxel is indicated. No further pre-selection is allowed. Descriptive analysis will be performed. Side effects which were not observed so far will be reported
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Efficacy and tolearability in routine practice

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Secondary Outcome

Side effects which were not reported so far

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/12/01
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Signed and dated consent is available
- The treatment decision was made independently of a possible inclusion in the study
- Patient is not at the same time a clinical trial participant
- Patient is at least 18 years old.

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Exclusion Criteria

- Patient is pregnant

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Addresses

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    • Axios Pharma GmbH
    • Kammerichstrasse 39
    • 33647  Bielefeld
    • Germany
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    • Datafaber GbR
    • Dr  Burkard  Heckelbacher 
    • Kantstrasse 15
    • 85356  Freising
    • Germany
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    • Gemeinschaftspraxis Dr.med. Wolfgang Dietz und Gudrun Witte-Dietz
    • Mr.  Dr. med.  Wolfgang  Dietz 
    • Albert-Schweitzer-Straße 18
    • 38228  Salzgitter
    • Germany
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    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstrasse 39
    • 33647  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.