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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 : Unknown
Verified April 2018 by Institut Curie.
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2012
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ductal Infiltrating Metastatic Breast Cancer Hormone-receptors Positive Breast Cancer Biological: Circulating tumor cells counting at baseline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2012
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival evaluation [ Time Frame: 2 years ]
    According to RECIST 1.1 criteria

  2. Economic evaluation [ Time Frame: 2 years ]
    Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)


Secondary Outcome Measures :
  1. Assessing patient quality of life [ Time Frame: 2 years ]
    QLQC30 and BR23 individual questionaries

  2. 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.

  3. Overall survival evaluation [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710605


Locations
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Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Jean-Yves Pierga Institut Curie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01710605    
Other Study ID Numbers: IC 2011-09
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Institut Curie:
Circulating tumor cells
Breast Cancer
Hormone-receptors positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes