Efficacy and toxicity of Trastuzumab at the maintaining dose of 1 mg/kg/week versus the standard dose of 2 mg/kg/week in combination with chemotherapy in metastatic breast cancer patients. A phase III multicenter study. - Dose optimization of Trastuzumab

Conditions: HER-2 positive metastatic breast cancer
MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2007-006060-29-IT

Lead Sponsor: IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Female gender
2. Age > 18 years
3. ECOG Performance Status 0-1 (Appendix II)
4. Histological diagnosis of breast cancer with evidence of metastatic or recurrent disease. Lesions should not be amenable to surgery or radiation for curative intent.
5. Baseline LVEF ≥ 50 measured by echocardiography or MUGA scan
6. Overexpression of HER2 (Appendix IV)
7. Indication to treatment with chemotherapy + Trastuzumab.
8. Previous hormonal therapy for both adjuvant and metastatic disease is allowed.
9. Previous adjuvant and/or neo-adjuvant chemotherapy is allowed
10. Previous Trastuzumab therapy for adjuvant treatment is allowed
10. Estimated life expectancy of at least 12 weeks.
11. Adequate bone marrow, liver and renal function.
12. Signed written informed consent obtained prior to study screening procedures.
13. Patients with reproductive potential must use an approved contraceptive method if appropriate (except hormonal substitutive therapy) during and for 3 months after stopping treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

1. Past or current history of malignant neoplasms except for curatively treated ones. The following malignant neoplasms if curatively treated, do not preclude patient inclusion: basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix, any cancer that has been curatively treated, with no evidence of disease, and a <15% risk of recurrence over the next 10 years, previous ductal carcinoma in situ of the breast
2. Prior use of anti-HER2 therapy for metastatic disease
3. Prior chemotherapy for metastatic disease
4. Concurrent anti-cancer treatment with an investigational drug.
5. Concurrent serious medical condition or cardiac illness or severe pulmonary conditions/illness. Serious cardiac illness which lead to patient exclusion (ineligible) include but are not confined to :
a. History of documented congestive heart failure (CHF)
b. High-risk uncontrolled arrhythmias
c. Angina pectoris requiring antianginal medication
d. Clinically significant valvular heart disease
e. Evidence of transmural infarction on ECG
f. Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic greater than 100mm Hg)
6. Pregnant or lactating women
7. Patients with clinical evidence of symptomatic brain metastasis