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)
This study is currently recruiting participants.
Verified November 2012 by Institut Claudius Regaud
Sponsor:
Institut Claudius Regaud
Information provided by (Responsible Party):
Muriel POUBLANC, Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01574170
First received: March 16, 2012
Last updated: November 6, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer Starting a Third Line Chemotherapy |
Other: Construction of a prognostic score (non-drug intervention types) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Institut Claudius Regaud:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Quality of life using the EORTC QLQ-C15-PAL Questionnaire [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0 [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 270 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women of more than 18 years old
- WHO 0-4
- Metastatic breast cancer
- Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy
- Evaluable disease
- Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2
- Patient able to complete the EORTC PAL 15 Questionnaire
- Patient member in a national insurance scheme
- Informed consent obtained and signed by the patient
Exclusion Criteria:
- History of other (s) cancer (s) potentially metastatic (s)
- Woman participating in a third line chemotherapy clinical trial
- Pregnant women or nursing mothers can not participate in the study
- Patient under legal guardianship
- Patient unable to undergo medical test for various reasons including social or psychological reasons.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574170
Contacts
| Contact: Florence Md DALENC | +33 5.61.42.41.28 | Dalenc.florence@claudiusregaud.fr |
Locations
| France | |
| Institut de Cancérologie de l'Ouest Paul Papin | Recruiting |
| Angers, France, 49933 | |
| Contact: Patrick SOULIE, PhD + 33 2 41 35 27 34 p.soulié@unimedia.fr | |
| Principal Investigator: Patrick SOULIE, PhD | |
| Sub-Investigator: Sophie ABADIE LACOURTOISIE, PhD | |
| Sub-Investigator: Rémy DELVA, PhD | |
| Sub-Investigator: Olivier Joseph CAPITAIN, PhD | |
| Sub-Investigator: Philippe MAILLART, PhD | |
| CHRU Brest | Recruiting |
| Brest, France, 26609 | |
| Contact: Hélène SIMON, PhD +33 2 98 22 33 95 helene.simon@chu-brest.fr | |
| Principal Investigator: Hélène SIMON, PhD | |
| Sub-Investigator: Brigitte LUCAS, PhD | |
| Centre Georges François Leclerc | Recruiting |
| Dijon, France, 21079 | |
| Contact: Isabelle DESMOULINS, PhD +33 3 45 34 80 51 idesmoulins@cgfl.fr | |
| Principal Investigator: Isabelle DESMOULINS, PhD | |
| Sub-Investigator: Séverine GUIU, PhD | |
| Sub-Investigator: Bruno COUDERT, PhD | |
| Sub-Investigator: Françoise MAYER, PhD | |
| Institut Curie | Not yet recruiting |
| Paris, France, 75005 | |
| Contact: Jean-Yves PIERGA, PhD +33 1 44 32 42 76 Jean-yves.pierga@curie.net | |
| Principal Investigator: Jean-Yves PIERGA, PhD | |
| Centre Eugène Marquis | Not yet recruiting |
| Rennes, France, 35042 | |
| Contact: Pierre KERBRAT, PhD +33 2 99 25 32 80 kerbrat@rennes.fnclcc.fr | |
| Principal Investigator: Pierre KERBRAT, PhD | |
| Sub-Investigator: Claudia LEFEUVRE, PhD | |
| Sub-Investigator: Elodie VAULEON, PhD | |
| Sub-Investigator: Daniel GEDOUIN, PhD | |
| Sub-Investigator: Julien EDELINE, PhD | |
| Institut Claudius Regaud | Recruiting |
| Toulouse, France, 31052 | |
| Contact: Florence DALENC, PhD +33 5.61.42.41.28 Dalenc.florence@claudiusregaud.fr | |
| Sub-Investigator: Laurence GLADIEFF, PhD | |
| Sub-Investigator: Jean-Louis LACAZE, PhD | |
| Sub-Investigator: Henri ROCHE, Pr | |
| Principal Investigator: Florence DALENC, PhD | |
| CHU Rangueil | Recruiting |
| Toulouse, France, 31000 | |
| Contact: Marion DESLANDRES, PhD + 33 5 61 32 36 16 deslandres.m@chu-toulouse.fr | |
| Principal Investigator: Marion DESLANDRES, PhD | |
| Sub-Investigator: Pascale RIVERA, PhD | |
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
| Principal Investigator: | Florence MD DALENC | Institut Claudius Regaud |
More Information
No publications provided
| Responsible Party: | Muriel POUBLANC, Principal investigator, Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT01574170 History of Changes |
| Other Study ID Numbers: | 11 SEIN 07 |
| Study First Received: | March 16, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Claudius Regaud:
|
Breast cancer, Third line metastatic Chemotherapy, Overall survival, Quality of life. |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013