Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT01414933
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01414933
Study Brief:
Protocol Section:
NCT01414933