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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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ClinicalTrials.gov Identifier: NCT01710605
Recruitment Status : Active, not recruiting
First Posted : October 19, 2012
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date  ICMJE August 10, 2012
First Posted Date  ICMJE October 19, 2012
Last Update Posted Date April 9, 2018
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
  • Progression free survival evaluation [ Time Frame: 2 years ]
    According to RECIST 1.1 criteria
  • Economic evaluation [ Time Frame: 2 years ]
    Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01710605 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
  • Assessing patient quality of life [ Time Frame: 2 years ]
    QLQC30 and BR23 individual questionaries
  • 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.
  • Overall survival evaluation [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ductal Infiltrating Metastatic Breast Cancer
  • Hormone-receptors Positive Breast Cancer
Intervention  ICMJE Biological: Circulating tumor cells counting at baseline
20 ml blood sample collected before randomization
Study Arms
  • Active Comparator: Standard
    Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.
    Intervention: Biological: Circulating tumor cells counting at baseline
  • 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

    Intervention: Biological: Circulating tumor cells counting at baseline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 6, 2018)
800
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2012)
1000
Estimated Study Completion Date September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01710605
Other Study ID Numbers  ICMJE IC 2011-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Institut Curie
Study Sponsor  ICMJE Institut Curie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Yves Pierga Institut Curie
PRS Account Institut Curie
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP