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

April 6, 2018 updated by: Institut Curie

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital Tenon
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Saint-cloud, France, 92210
        • Institut Curie - Hopital Rene 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 years
According to RECIST 1.1 criteria
2 years
Economic evaluation
Time Frame: 2 years
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
Time Frame: 2 years
QLQC30 and BR23 individual questionaries
2 years
Evaluation of treatment safety according to NCI-CTCAEv4.03
Time Frame: 2 years
Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.
2 years
Overall survival evaluation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: Jean-Yves Pierga, Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2011-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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