Status:
COMPLETED
High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Ministry of Health, France
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together wi...
Eligibility Criteria
Inclusion
- Men and Women with histologically diagnosed breast cancer
- Metastatic relapse or stage IV breast cancer at diagnosis
- Metastases amenable to biopsy
- Age \<70 years old
- PS 0/1
- No restriction regarding the number of previous chemotherapy or endocrine therapies
Exclusion
- Age \<18
- Life expectancy \<3 months
- Symptomatic or progressing brain metastases
- Progressive patients at the time of biopsy
- LVEF \<50% (MUGA or ultrasonography)
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count \< 1.5 x 109/L
- Platelet count \< 100 x 109/L
- Haemoglobin \< 90 g/L
- ASAT/ALAT \> 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or \> 5 times ULN in the presence of liver metastases
- Total bilirubin \> 1.5 times ULN
- Creatinine \>1.5 times ULN
- Corrected calcium \> ULN
- Phosphate \> ULN
- Abnormal blood coagulation that contra-indicates biopsy
- Patients deprived of liberty or placed under the authority of a tutor
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT01414933
Start Date
May 1 2011
End Date
May 1 2013
Last Update
May 4 2017
Active Locations (18)
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1
Institut Bergonié
Bordeaux, France
2
Centre François Baclesse
Caen, France
3
Centre Georges François Leclerc
Dijon, France
4
Centre Oscar Lambret
Lille, France