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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

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Circulating tumor cells counting at baseline
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Infiltrating Metastatic Breast Cancer focused on measuring Circulating tumor cells, Breast Cancer, Hormone-receptors positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre François Baclesse
  • Centre Georges Francois Leclerc
  • Clinique Victor Hugo
  • Centre Leon Berard
  • Institut Paoli Calmettes
  • Chu Montpellier
  • Institut régional du Cancer de Montpellier
  • Centre Azureen de Cancerologie
  • Centre Antoine Lacassagne
  • Institut Curie
  • Hopital SAINT-LOUIS
  • Hopital Europeen Georges Pompidou
  • Hopital Tenon
  • Institut Curie - Hopital Rene Huguenin
  • Institut de Cancerologie de L'Ouest - Rene Gauducheau
  • Institut Claudius Regaud
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Circulating Tumor Cells

Arm Description

Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2012
Last Updated
April 6, 2018
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT01710605
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Infiltrating Metastatic Breast Cancer, Hormone-receptors Positive Breast Cancer
Keywords
Circulating tumor cells, Breast Cancer, Hormone-receptors positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.
Arm Title
Circulating Tumor Cells
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Circulating tumor cells counting at baseline
Intervention Description
20 ml blood sample collected before randomization
Primary Outcome Measure Information:
Title
Progression free survival evaluation
Description
According to RECIST 1.1 criteria
Time Frame
2 years
Title
Economic evaluation
Description
Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Assessing patient quality of life
Description
QLQC30 and BR23 individual questionaries
Time Frame
2 years
Title
Evaluation of treatment safety according to NCI-CTCAEv4.03
Description
Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.
Time Frame
2 years
Title
Overall survival evaluation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Pierga
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Institut régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Azureen de Cancerologie
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital SAINT-LOUIS
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Curie - Hopital Rene Huguenin
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancerologie de L'Ouest - Rene Gauducheau
City
Saint-herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33151266
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.
Results Reference
derived

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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

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