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Clinical Trials/EUCTR2012-000393-35-IT
EUCTR2012-000393-35-IT
Active, not recruiting
Not Applicable

a multicenter phase II trial of nab-paclitaxel and capecitabine as first line treatment in Her-2 negative metastatic breast cancer (MBC) - protocol GOIM 21002

GOIM GRUPPO ONCOLOGICO MERIDIONALE0 sitesMarch 30, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Status
Active, not recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 30, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
GOIM GRUPPO ONCOLOGICO MERIDIONALE

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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