The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if \<5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
20 ml blood sample collected before randomization
Centre François Baclesse
Caen, France
Centre Georges Francois Leclerc
Dijon, France
Clinique Victor Hugo
Le Mans, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Chu Montpellier
Montpellier, France
Institut régional du Cancer de Montpellier
Montpellier, France
Centre Azureen de Cancerologie
Mougins, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
...and 7 more locations
Progression free survival evaluation
According to RECIST 1.1 criteria
Time frame: 2 years
Economic evaluation
Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
Time frame: 2 years
Assessing patient quality of life
QLQC30 and BR23 individual questionaries
Time frame: 2 years
Evaluation of treatment safety according to NCI-CTCAEv4.03
Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.
Time frame: 2 years
Overall survival evaluation
Time frame: 2 years
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