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.

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 Overview

• Status: Unknown
• Conditions: Ductal Infiltrating Metastatic Breast Cancer; Hormone-receptors Positive Breast Cancer
• Intervention / Treatment: Biological: Circulating tumor cells counting at baseline

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Le Mans, France, 72000
    • Clinique Victor Hugo
  • Lyon, France, 69373
    • Centre Leon Berard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Montpellier, France, 34298
    • Institut Regional du Cancer de Montpellier
  • Montpellier, France, 34000
    • CHU Montpellier
  • Mougins, France, 06250
    • Centre Azuréen de Cancérologie
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75010
    • Hôpital Saint-Louis
  • Saint-cloud, France, 92210
    • Institut Curie - Hôpital René Huguenin
  • Saint-herblain, France, 44805
    • Institut de cancérologie de l'Ouest - René Gauducheau
  • Toulouse, France, 31052
    • Institut Claudius Regaud
  • Vandoeuvre Les Nancy, France, 54500
    • Centre Alexis Vautrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; 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; 20 ml blood sample collected before randomization
Experimental: Circulating Tumor Cells; 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; 20 ml blood sample collected before randomization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Jean-Yves Pierga, Institut Curie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; Circulating tumor cells; Hormone-receptors positive
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasm Metastasis; Breast Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: IC 2011-09