Clinical trial NCT01710605: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ductal Infiltrating Metastatic Breast Cancer
Hormone-receptors Positive Breast Cancer
Keywords: Circulating tumor cells
Breast Cancer
Hormone-receptors positive
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival evaluation
timeFrame: 2 years
measure: Economic evaluation
timeFrame: 2 years
Secondary outcomes:
measure: Assessing patient quality of life
timeFrame: 2 years
measure: Evaluation of treatment safety according to NCI-CTCAEv4.03
timeFrame: 2 years
measure: Overall survival evaluation
timeFrame: 2 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Chu Montpellier
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
city: Mougins
country: France
facility: Centre Azureen de Cancerologie
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital SAINT-LOUIS
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Tenon
city: Saint-cloud
country: France
facility: Institut Curie - Hopital Rene Huguenin
city: Saint-herblain
country: France
facility: Institut de Cancerologie de L'Ouest - Rene Gauducheau
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Institut Curie
name: Jean-Yves Pierga
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Goncalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espie M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Dieras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabieres C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.