From: Markers for the identification of late breast cancer recurrence
Trial | Study design | Reference |
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STIC CTC METABREAST | 1,000 hormone receptor-positive, metastatic breast cancer patients randomly assigned to either standard arm or CTC-driven arm, which dictates whether hormone therapy (5 CTCs <7.5 mL) or to chemotherapy (5 CTCs ≥7.5 mL) is administered. Trial aims to show non-inferiority of the CTC arm versus standard arm for progression-free survival. | [54] |
SWOG 0500 | Screening patients with metastatic disease and more than 5 CTCs (n = 610) and randomization between continuation of first-line therapy (CTC response, <5 CTC/7.5 mL) and switch to another chemotherapy regime (no CTC response, ≥5 CTCs/7.5 mL) (n = 120). Primary endpoint is improvement in overall survival in the CTC-driven arm. | [55] |
CirCe01 | 304 women with metastatic disease starting with third-line chemotherapy will be randomly assigned between a CTC-driven arm and standard care arm. Patients in the CTC-driven arm change chemotherapy regimens according to their CTC counts during treatment. Primary endpoint is overall survival. | [56] |
Treat CTC | Patients with HER2-negative breast cancer having completed chemotherapy and primary surgery and with at least 1 CTC/15Â mL will be randomly assigned to an observation arm or to receive trastuzamab. Primary endpoint is detection rate of CTCs after 18Â weeks between the two arms. | NCT01548677 |
DETECT III | Around 300 patients with metastatic and HER2-negative disease with detectable at least one HER2-positive CTC/7.5Â mL will be randomly assigned to receive standard care (endocrine or chemotherapy or both) versus standard care plus lapatinib. Primary endpoint is progression-free survival. | NCT01619111 |