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UnknownNCT01710605

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

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.

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
800 (actual)
Sponsor
Institut Curie · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCirculating tumor cells counting at baseline20 ml blood sample collected before randomization

Timeline

Start date
2012-02-01
Primary completion
2018-09-01
Completion
2018-09-01
First posted
2012-10-19
Last updated
2018-04-09

Locations

17 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01710605. Inclusion in this directory is not an endorsement.