EUCTR2012-002347-23-DK
Active, not recruiting
Not Applicable
Phase II study of irinotecan weekly in combination with trastuzumab in patientswith locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1” - POSIRI
Danish Breast Cancer Group (DBCG)0 sitesJune 27, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Danish Breast Cancer Group (DBCG)
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological or cytological confirmed adenocarcinoma of the breast
- •MBC with \= 4 TOP1 genes in the primary tumour.
- •Performance status 0\-2
- •Locally advanced or metastatic disease
- •HER2 positive disease
- •Measurable disease by RECIST 1\.1
- •Maximum 4 prior chemotherapy regiments for locally advanced or metastatic disease
- •Neutrophil count (ANC) \= 1,5 x 10?/l and platelet count \= 100 x 10?/l
- •Serum bilirubin \= 1\.5 x ULN
- •Serum transaminases \= 2\.5 x ULN
Exclusion Criteria
- •Other present or previous malignancy except curatively treated
- •cervical cancer stage I or non\-melanotic skin cancer
- •Cytotoxic or experimental treatment 2 weeks prior to inclusion
- •Pregnant or breast\-feeding. For fertile women a negative pregnancy
- •test at screening is mandatory.
- •Fertile patients not willing to use IUD as an acceptable and safe method of
- •contraception
- •CNS metastasis
- •Allergy to the ingredients of the study medication.
- •Patients who due to linguistic, culturel or incelectual reasons do not understand the protocol information
Outcomes
Primary Outcomes
Not specified
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