metastastic mammary cancer metastatic breast cancer
Conditions
Interventions
1x20 mL of blood will be drawn to screen patients for the presence of
HER2-positive CTCs. In patients with at least one HER2-positive CTC, an
additional 60 mL of blood will be drawn for CTC characte
Sponsors
Interne Oncologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Screening: Female patient with metastatic breast cancer with HER2-negative primary tumor Age >= 18 years old WHO performance status
Exclusion criteria
Exclusion criteria: Previous chemotherapy for metastatic disease. Adjuvant chemotherapy within 6 months prior to treatment start. Hormonal antitumor treatment within one week prior to treatment start. Symptomatic CNS metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is progression free survival rate at 6 months (PFR6mth) in patients with HER2-negative primary tumor but at least one HER2-positive CTC, receiving trastuzumab/taxane-based chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the association between 6 months PFR and PIK3CA mutation status, pHER2 expression and ER expression on CTC*s. In addition, the PIK3CA mutation status, HER2 and ER expression status will be re-evaluated on the primary tumor. Furthermore, CTC enumeration and characterization done following CellSearch procedures and CytoTrack procedures, respectively, will be compared. Lastly, it will be explored whether the % of HER2-positive CTCs correlates with response to trastuzumab/taxane-based chemotherapy. | — |
Countries
Netherlands
Outcome results
None listed