Non-interventional study on the safety and efficacy of an Abraxane(R) mono therapy for the therapy of patients with metasasized breast cancer with special consideration of the toxicity profiles

Non-interventional study on the safety and efficacy of an Abraxane(R) mono therapy for the therapy of patients with metasasized breast cancer with special consideration of the toxicity profiles - Abraham study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003203

Enrollment

450

Registered

2011-07-26

Start date

2011-09-01

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

C50

Interventions

Group 1: Observation group: Demographics, Anamnesis, Prior therapies, Diagnosis, Therapy data Abraxane®, Toxicity, Status of survival, Usage of GCSF, Adverse events (AE), Hospitalisation because of a

Eligibility

Sex/Gender

Female

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Secured metastasized breast cancer with at least 1 metastasis (by means of RECIST or diffuse metastasis of the skeloton) • Gender: female • Alge: =18 ýears • Signed patient informed consent • Therapy in a practice which is member of the BNGO • Adequate general condition = 2 on the ECOG Scale • Adequate bone marrow reserves: number of neutrophiles < 1,5 x 1E9 /L before start of the therapy

Exclusion criteria

Exclusion criteria: • Pregnancy and lactation • Lack of compliance

Design outcomes

Secondary

Measure	Time frame
Questions concerning cost of treatment: • Necessity of the application of GCSF (Granulocyte colony stimulating factor) • Necessary emergency and hospitalizations due to therapy related AE.	—

Primary

Measure	Time frame
•Progression free survival (PFS) •Overall survival (OS) •Safety after 3 months and after 9 months by means of the NCI CTCAE-criteria (National Cancer Institute, Common Terminology for Coding of Adverse Events)	—

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