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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Ductal Infiltrating Metastatic Breast Cancer, Hormone-receptors Positive Breast Cancer

Intervention / Treatment
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* Biological: Circulating tumor cells counting at baseline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with metastatic ductal adenocarcinoma breast cancer 18 years old or more Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available. Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration PS <4 Life expectancy > 3 months Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection Information of the patient and signature of the informed consent form Exclusion Criteria: Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted) Her2 positive breast cancer History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers). Persons deprived of their freedom or under guardianship. Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information. | Biological: Circulating tumor cells counting at baseline<br>* 20 ml blood sample collected before randomization<br>|
| Experimental: Circulating Tumor Cells<br>Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline : If <5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy | Biological: Circulating tumor cells counting at baseline<br>* 20 ml blood sample collected before randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival evaluation | According to RECIST 1.1 criteria | 2 years | 
| Economic evaluation | Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing patient quality of life | QLQC30 and BR23 individual questionaries | 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. | 2 years | 
| Overall survival evaluation |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumor cells, Breast Cancer, Hormone-receptors positive