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Non-Interventional study to review the guideline-conform dosage of chemotherapy with taxanes Eurotere® / Eurotaxel® as a monotherapy or combined therapy in everyday use for treatment of breast cancer depending on the age and the body surface

Non-Interventional study to review the guideline-conform dosage of chemotherapy with taxanes Eurotere® / Eurotaxel® as a monotherapy or combined therapy in everyday use for treatment of breast cancer depending on the age and the body surface - NIS ET-002

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009299
Enrollment
500
Registered
2016-01-28
Start date
2015-08-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: In patients with breast cancer the compatibility and efficacy of Eurotere(R) / Eurotaxel(R) in the routine application will be recorded. The evaluation of the compatibility will be done by us

Sponsors

Lapharm GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Histologically confirmed mamma carcinoma • Age: = 18 Years • Signed patient consent form • Therapy in practice, which belongs to BNGO

Exclusion criteria

Exclusion criteria: • Pregnancy, breastfeeding period • Poor Compliance

Design outcomes

Primary

MeasureTime frame
• Progression Free Survival (PFS) - timeframe: observation phase for 9 months per patient

Secondary

MeasureTime frame
• influence of age (= 65 years versus > 65 years) and of body surface on dosage • influence of BMI ( 30 kg/m²) on therapy and PFS • tolerability on the NCI CTCAE criteria • efficacy based on the objective response rate Measuring times: 1. first prescription of Eurotere(R) / Eurotaxel(R) as part of the NIS, 2. 90 days after the first prescription of Eurotere(R) / Eurotaxel(R), 3. nine months after the first prescription of Eurotere(R) / Eurotaxel(R)

Countries

Germany

Contacts

Public ContactAnne-Katrin Ullner

OnkoDataMed GmbH

info@onkodatamed.de03342/42689-10

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026