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Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival (METAL3)

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ClinicalTrials.gov Identifier: NCT01574170
Recruitment Status : Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Tracking Information
First Submitted Date  ICMJE March 16, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE June 18, 2012
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data) [ Time Frame: 7 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
  • The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression [ Time Frame: 7 years ]
  • Quality of life using the EORTC QLQ-C15-PAL Questionnaire [ Time Frame: 7 years ]
  • Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas [ Time Frame: 7 years ]
  • Oncologists satisfaction regarding the management and communication with the patient will be studied at baseline and at the time or progression using the Likert ordinal scale [ Time Frame: 7 years ]
  • Regret or not of the patient to have followed a 3rd line of chemotherapy will be recorded at the end of the treatment using the "Decision regret scale" Questionnaire, established by A. O'Connor [ Time Frame: 7 years ]
  • Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival
Official Title  ICMJE Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival
Brief Summary

This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.

This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.

The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.

This score will then be validated on the 2nd cohort.

There will be no interruption of inclusions between first and second cohort of patients

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Breast Cancer Starting a Third Line Chemotherapy
Intervention  ICMJE Other: Construction of a prognostic score (non-drug intervention types)
Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression
Study Arms  ICMJE Not Provided
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: July 3, 2020)
267
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2012)
270
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women of more than 18 years old
  2. WHO 0-4
  3. Metastatic breast cancer
  4. Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy
  5. Evaluable disease
  6. Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2
  7. Patient able to complete the EORTC PAL 15 Questionnaire
  8. Patient member in a national insurance scheme
  9. Informed consent obtained and signed by the patient

Exclusion Criteria:

  1. History of other (s) cancer (s) potentially metastatic (s)
  2. Woman participating in a third line chemotherapy clinical trial
  3. Pregnant women or nursing mothers can not participate in the study
  4. Patient under legal guardianship
  5. Patient unable to undergo medical test for various reasons including social or psychological reasons.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT01574170
Other Study ID Numbers  ICMJE 11 SEIN 07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Florence MD DALENC Institut Claudius Regaud
PRS Account Institut Claudius Regaud
Verification Date July 2021

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