Phase II study in patients suffering from metastatic breast cancer Her2neg, The Line, randomized (1:1) with two arms.

• Conditions: patients wiyh metastatic breast cancer her2 negative first line treatment; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001325-28-IT
• Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• histologically proven breast carcinoma Her-2 negative • Age 18-75 years • State of validity (WHO) = 2 • Disease stage IIIB / IV with the presence of at least one measurable lesion unidimensionalmente • Any previous adjuvant / neoadjuvant chemotherapy completed at least 1 year • Any previous adjuvant hormone therapy or in advanced disease with documented progression • Possible previous RT including not more than 30% of the skeleton containing bone marrow and terminated by at least 4 weeks • Adequate bone marrow function (GB 4.000/mm3 =, = 2.000/mm3 neutrophils, platelets = 100.000/mm3), hepatic (bilirubin = 1.5mg%), renal (creatinine = 1.2mg%) • Negative pregnancy test (urine or serum) made ??within 7 days prior to entry into the study in women of childbearing age, these patients should take effective non-hormonal contraception for the duration of treatment • The pre-manopausali patients with endocrine responsive disease can be treated with LH-RH analogue, the measurement of any ovarian activity with serum tests should be performed only once at baseline study. • Geographical Accessibility for follow-up • Written Informed Consent
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

• • Previous chemotherapy for metastatic disease or concomitant therapy with hormonal agents or biotherapy • Previous adjuvant / neoadjuvant chemotherapy with attainment of the maximum cumulative dose of Adriamycin of 450 mg / sqm and epirubicin of 900 mg / sqm. • symptomatic brain metastases • psychological disorders precluding the obtaining of informed consent • Other cancers (except basal or squamous cell skin cancers and carcinoma in situ of the cervix, if adequately treated) • LVEF <50% determined by echocardiogram or MUGA scan • Patients who are pregnant • uncontrolled arterial hypertension (systolic = 150 mmHg and / or diastolic = 100 mmHg) • Cardiovascular disease clinically active (eg acute myocardial infarction within 6 months prior to enrollment in this study, NYHA Class II CHF, severe cardiac arrhythmia, which may require medical treatment during the study and could interfere with the regularity of treatment, or is not controlled by medical treatment) • Leukocytes <4000/mmc, neutrophils <2000/mmc, platelets <100000/mmc • Impaired renal function (creatinine ? 1.25 times normal) or hepatic (GOT or GPT ? 1.25 times the normal values, unless the disease is not due to liver metastases) • Concomitant treatment with other experimental drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluate the performance in terms of response rates (RR) and quality of life;Secondary Objective: evaluate time to progression (PFS) and overall survival (OS);Primary end point(s): evaluate the performance in terms of response rates (RR) and quality of life;Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): assess time to progression (PFS) and overall survival (OS);Timepoint(s) of evaluation of this end point: 2 years