trastuzumab, docetaxel and oxaliplatino association in metastatic breast cancer with her2 receptor overexepression Phase II clinical trial - HOT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000413-37-IT

Enrollment

Registered

2006-06-05

Start date

2006-10-11

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Females with metastatic breah cancer with her2 receptor overexepression and PERFORMANCE STATE-PS ECOG from 0 to 2 MedDRA version: 6.1 Level: PT Classification code 10055113

Interventions

Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Trastuzumab CAS Number: 180288-69-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6- Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological diagnosis of breast cancer - HER2 overexpression immune histological determination with positivity score 3 or 2 FISH confirmed - Instrumental evidence for metastatic diffusion measurable disease; RECIST parameters - Patients aged 18 to 70 years - PS ECOG between 0 and 2 - Life expectancy 6 months - Adequate bone marrow functionality leucocytes 8805; 3.0 109/L, neutrophils 1.5 109/L, platelets 8805; 100 109/L, haemoglobin 9g/dl - Adequate hepatic functionality total bilirubin 8804; 1.25 x UNV, transaminase 8804;3 x UNV, alkaline phosphatase 8804;2.5xUNV - Adequate renal functionality creatinine 8804;1.3 x UNV - Cardiac ejection fraction equal at least to 50 - Any concluded adjuvant or metastatic disease hormonal treatment has admitted - Premenopausal women using effective methods off birth controll and negative pregnancy test on 2 weeks before chemotherapy s beginning - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous chemotherapy treatment for metastatic disease - Previous treatment with Docetaxel in adjuvant or neoadjuvant therapy - Presence of symptomatic cerebral metastases - Radiotherapy on only valutation target - Acute myocardial infarction during the last year - Adequate follow up no possible - no compensate metabolic diseases or infection in act - arithmin cardiac or no control cardiopathic ischemia - Pregnant patients

Design outcomes

Primary

Measure	Time frame
Main Objective: Overall response rate ORR and clinical benefit ORR SD 6 mesi Tolerability;Secondary Objective: Time to progression -TP Overal Survival -OS Quality of life;Primary end point(s): Overall response rate ORR and clinical benefit ORR SD 6 mesi Tolerability	—

Countries

Italy

Outcome results

None listed

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