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Liposomial pegylate doxorubicine and trasuzumab in the first line treatment of the metastatised Her2 positive breast cancer for senior women - ND

Liposomial pegylate doxorubicine and trasuzumab in the first line treatment of the metastatised Her2 positive breast cancer for senior women - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-007089-12-IT
Enrollment
Unknown
Registered
2007-05-22
Start date
2007-02-07
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Metastased breast cancer, first line treatment, for women with age>70 years old,Her2 positive MedDRA version: 9.1 Level: LLT Classification code 10006279 Term: Breast neoplasm

Interventions

Trade Name: CAELYX*INFUS 1FL 2MG/ML 25ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg milligram(s) Concentration type: equal Conce

Sponsors

GOIM GRUPPO ONCOLOGICO MERIDIONALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Breast cancer istologically assured, age>70 years old, validity state (WHO)=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous chemoteraphy for metastatic desease, concomitant serious deseases(cardiovascular, renal, hepatic,etc.), cardiopathy pre-existing with cardiac insufficiency

Design outcomes

Primary

MeasureTime frame
Main Objective: To consider the activity of the chemoteraphic combination with the percentage of obiective responses;Secondary Objective: To consider the toxicity of the treatment, in particular the cardiac toxicity, to consider the progression time and global survival, to consider the reduction of the hospital costs;Primary end point(s): To consider the efficacy and the tolerability of the chemoteraphic combination—

Countries

Italy

Outcome results

None listed

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