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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Institut Curie
Sponsor:
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
NCT01710605
First received: August 10, 2012
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Progression free survival evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    According to RECIST 1.1 criteria

  • Economic evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)


Secondary Outcome Measures:
  • Assessing patient quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    QLQC30 and BR23 individual questionaries

  • Evaluation of treatment safety according to NCI-CTCAEv4.03 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.

  • Overall survival evaluation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710605

Contacts
Contact: Patricia Tresca, MD +33156245765 emmanuelle.bouffier@curie.net

Locations
France
Centre Georges Francois Leclerc Not yet recruiting
Dijon, France, 21079
Contact: Sylvain LADOIRE, DR         
Hopital de La Timone Not yet recruiting
Marseille, France, 13005
Contact: FLORENCE DUFFAUD, DOCTOR         
Institut Paoli Calmettes Not yet recruiting
Marseille, France, 13009
Contact: ANTHONY GONCALVES, DOCTOR         
Centre Val D'Aurelle - Paul Lamarque Active, not recruiting
Montpellier, France, 34298
Chu Montpellier Not yet recruiting
Montpellier, France, 34000
Contact: DELPHINE TOPART, DOCTOR         
Centre Azureen de Cancerologie Not yet recruiting
Mougins, France, 06250
Contact: HERVE NAMAN, DOCTOR         
Centre Antoine Lacassagne Not yet recruiting
Nice, France, 06189
Contact: JEAN-MARC FERRERO, DOCTOR         
Institut Curie Recruiting
Paris, France, 75005
Contact: JEAN-YVES PIERGA, PROFESSOR         
Hopital Europeen Georges Pompidou Not yet recruiting
Paris, France, 75015
Contact: JACQUES MEDIONI, DOCTOR         
Institut Curie Recruiting
Paris, France, 75005
Contact: Jean-Yves Pierga, MD         
Institut Curie - Hopital Rene Huguenin Recruiting
Saint-cloud, France, 92210
Contact: ETIENNE BRAIN, DOCTOR         
Institut de Cancerologie de L'Ouest - Rene Gauducheau Not yet recruiting
Saint-herblain, France, 44805
Contact: MARIO CAMPONE, DOCTOR         
Institut Claudius Regaud Not yet recruiting
Toulouse, France, 31052
Contact: FLORENCE DALENC, DOCTOR         
Centre Alexis Vautrin Active, not recruiting
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Jean-Yves Pierga Institut Curie
  More Information

No publications provided

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01710605     History of Changes
Other Study ID Numbers: IC 2011-09
Study First Received: August 10, 2012
Last Updated: October 18, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Institut Curie:
Circulating tumor cells
Breast Cancer
Hormone-receptors positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014