a multicenter phase II trial of nab-paclitaxel and capecitabine as first line treatment in Her-2 neg. metastatic breast cancer

• Conditions: metastatic breast cancer (MBC) Her-2 negative as 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: EUCTR2012-000393-35-IT
• Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-30
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

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

Inclusion Criteria

1. documented diagnosis of Her-2 neg o triple neg metastatic breast cancer, 2. age > o = 18 years, 3. no prior chemiotherapy for metastatic disease, 4. previous hormonal therapy as adjuvant or as I line treatment is allowed, 5. previous therapy with taxanes is allowed as adjuvant or neoadjuvant treatment if completed from at least 6 months, 6. previous treatment with anthracyclines is not mandatory, 7. PS 0-1, 8. consens informed
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 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion Criteria

1. documented brain metastases, 2. sensory neuropathy more than grade 1, 3. positive pregnancy test

Study & Design

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