Metastatic Breast Cancer Starting a Third Line ChemotherapyPhase 4METAL3NCT01574170
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
A Phase 4 study testing Construction of a prognostic score (non-drug intervention types) in people with Metastatic Breast Cancer Starting a Third Line Chemotherapy, run by Institut Claudius Regaud at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer Starting a Third Line Chemotherapy
- What is being tested?
- Construction of a prognostic score (non-drug intervention types)
- How many people
- 267 participants
- Where
- 16 sitesFrance
- Study dates
- 18 Jun 2012to 31 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Patient able to complete the EORTC PAL 15 Questionnaire
- Patient member in a national insurance scheme
- Informed consent obtained and signed by the patient
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
C.M.C.O. Claude Bernard
Albi, 81000
Institut de Cancérologie de l'Ouest Paul Papin
Angers, 49933
CHU Jean Minjoz
Besançon, 25030
CHRU Brest
Brest, 26609
Centre Hospitalier Jean Rougier
Cahors, 46005
Centre Hospitalier Intercommunal de Castres-Mazamet
Castres, 81108
Centre d'Oncologie et de Radiothérapie du Parc
Dijon, 21000
Centre Georges François Leclerc
Dijon, 21079
Clinique La Croix du Sud
Quint-Fonsegrives, 31130
Centre Eugène Marquis
Rennes, 35042
Centre Hospitalier de Rodez
Rodez, 12000
Centre Paul Strauss
Strasbourg, 67065
Polyclinique de l'Ormeau
Tarbes, 65000
CHU Rangueil
Toulouse, 31000
Institut Claudius Regaud
Toulouse, 31052
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
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.
Read more
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
- Being tested
- Construction of a prognostic score (non-drug intervention types)
- Keywords
- Breast cancer,, Third line metastatic, Chemotherapy,, Overall survival,, Quality of life.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Construction of a prognostic score (non-drug intervention types)Other
Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
Measured: 11 years
Secondary outcomes (6)
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Measured: 11 years
Quality of life using the EORTC QLQ-C15-PAL Questionnaire
Measured: 11 years
Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
Measured: 11 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
Measured: 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
Measured: 11 years
Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study start18 Jun 2012
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast Cancer Starting a Third Line ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence MD DALENC, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574170
- Sponsor's protocol ID
- 11 SEIN 07
- Acronym
- METAL3
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2012
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.
PubMed 25460338
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01574170
- Acronym / sponsor ID
- METAL3 / 11 SEIN 07
- Keywords
- Breast cancer,, Third line metastatic, Chemotherapy,, Overall survival,, Quality of life.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 18 Jun 2012 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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: 11 years
6 secondary outcomes
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Time frame: 11 years
Quality of life using the EORTC QLQ-C15-PAL Questionnaire
Time frame: 11 years
Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas
Time frame: 11 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: 11 years
Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0
Time frame: 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 25460338Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence MD DALENC principal investigator
Institut Claudius Regaud
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Construction of a prognostic score (non-drug intervention types) in people with Metastatic Breast Cancer Starting a Third Line Chemotherapy, run by Institut Claudius Regaud at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 11 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01574170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.