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PHASE IV.II, CLINICAL TRIAL, WITH THE COMBINATION OF PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CYCLOPHOSPHAMIDE AND TRASTUZUMAB (HERCEPTIN) IN PATIENTS WITH METASTATIC BREAST CANCER WITH OVEREXPRESSION OF HER2/NEU.

PHASE IV.II, CLINICAL TRIAL, WITH THE COMBINATION OF PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CYCLOPHOSPHAMIDE AND TRASTUZUMAB (HERCEPTIN) IN PATIENTS WITH METASTATIC BREAST CANCER WITH OVEREXPRESSION OF HER2/NEU.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001117-17-ES
Enrollment
49
Registered
2005-11-30
Start date
2005-11-30
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

PATIENTS WITH METASTATIC BREAST CANCER AND OVEREXPERSSION OF HER2NEU

Interventions

Trade Name: CAELYX Product Name: CAELYX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin hydrochloride (pegylated liposomal) Concentration unit: mg/ml millig

Sponsors

GEICAM (GRUPO ESPAÑOL DE INVESTIGACION EN CANCER DE MAMA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PATIENTS MUST SIGN AN INFORMED CONSENT BEFORE OF ESPECIFIC PROCEDURES OF CLINICAL TRIAL. PATIENTS WITH HISTOLOGICALLY CONFIRMED BREAST CANCER AND OVEREXPRESSION OF HER2 NEU. AGE > 18 YEARS. ECOG EQUAL OR =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: PATIENTS WITH HYPERSENSITIVITY REACTIONS TO ANY OF THE MADICATIONS OF THE CLINICAL TRIAL. PATIENTS WHO ARE PREGNANT OR LACTATING ARE NOT ELIGIBLE. HEPATIC DISEASE. NOT CONTROLLED ACTIVE INFECTION. SYMPTOMATIC METASTATIS BRAIN CANCER. PREVIOUS ADYUVANT TREATMENT WITH ANTRHACYCLINES WITH A TOTAL ACCUMULATED DOSE > 300 mg/m2 (DOXORUBICIN) OR > 600 mg/m2 (EPIRUBICIN).

Design outcomes

Primary

MeasureTime frame
Main Objective: TO EVALUATE OBJECTIVE RESPONSE RATE;Secondary Objective: TO EVALUATE THE PROFILE OF TOXICITY TO EVALUATE TIME TO PROGRESSION TO EVALUATE OVERALL SURVIVAL TO DETERMINATE DURATION OF RESPONSE TO DETERMINATE TIME TO FAILURE OF TREATMENT;Primary end point(s): TO EVALUATE OBJECTIVE RESPONSE RATE AFTER TREATMENT.—

Countries

Spain

Outcome results

None listed

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