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Non-interventional study about safety and efficacy of chemo-therapy with Paclitaxel Stragen(R) / Eurotaxel(R) (new name of the prescription) as mono or combined therapy for routine treatment of ovarial or breast cancer with special consideration of age and BMI starting position.

Non-interventional study about safety and efficacy of chemo-therapy with Paclitaxel Stragen(R) / Eurotaxel(R) (new name of the prescription) as mono or combined therapy for routine treatment of ovarial or breast cancer with special consideration of age and BMI starting position. - ET-001

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000781
Enrollment
1500
Registered
2011-04-11
Start date
2011-06-01
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

Breast cancer, ovarial cancer

Interventions

Group 1: Observation group: Patients receive chemotherapy with Paclitaxel Stragen(R) / Eurotaxel(R) (new name of the prescription) according to physician's prescription. Parameters of differentiation

Sponsors

Lapharm GmbH
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically secured ovarial or breast cancer. Signed patient informed consent form.

Exclusion criteria

Exclusion criteria: Pregnancy. Other malign diseases in the past 5 years. Lack of compliance.

Design outcomes

Primary

MeasureTime frame
Primary Outcome is progression free survival (PFS) measured after 3 and 9 months by means of the tumor response (complete remission, partial remission, abjictive stabilisation, objective progression). Overall Survival (OS) is measured after 9 months or by the occurence of a corresponding SAE.

Secondary

MeasureTime frame
Influence of age ( 65 years) on therapy, PFS and OS. Influence of BMI ( 30 kg / m² ) on therapy, PFS and OS. The measurements of age, height and weight are performed at therapy start, after 3 and after 9 months. Statistical tests are performed to secure a significant difference between the subgroups. Safety is measured by means of NCI CTCAE citeria by the investigator after 3 and 9 months.

Countries

Germany

Contacts

Public ContactHeribert Stiegler

OnkoDataMed GmbH

heribert.stiegler@onkodatamed.de030 / 64 38 75 60

Outcome results

None listed

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