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

Phase 3

• Conditions: Hormone-receptors Positive Breast Cancer; Ductal Infiltrating Metastatic Breast Cancer
• Interventions: Biological: Circulating tumor cells counting at baseline

• Registration Number: NCT01710605
• Lead Sponsor: Institut Curie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-19
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-09
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Circulating tumor cells counting at baseline	Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.
Circulating Tumor Cells	Circulating tumor cells counting at baseline	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

Primary Outcome Measures

Name	Time	Method
Progression free survival evaluation	2 years	According to RECIST 1.1 criteria
Economic evaluation	2 years	Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)

Secondary Outcome Measures

Name	Time	Method
Evaluation of treatment safety according to NCI-CTCAEv4.03	2 years	Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.
Overall survival evaluation	2 years
Assessing patient quality of life	2 years	QLQC30 and BR23 individual questionaries

Trial Locations

Locations (17)

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Institut régional du Cancer de Montpellier; 🇫🇷 Montpellier, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hopital SAINT-LOUIS; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Institut Curie - Hopital Rene Huguenin; 🇫🇷 Saint-cloud, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre Les Nancy, France

Institut de Cancerologie de L'Ouest - Rene Gauducheau; 🇫🇷 Saint-herblain, France

Centre François Baclesse; 🇫🇷 Caen, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Chu Montpellier; 🇫🇷 Montpellier, France

Centre Azureen de Cancerologie; 🇫🇷 Mougins, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France