Breast CancerBC-BIONCT01521676
Predictive Clinical and Biological Parameters in Breast Cancer
A study testing molecular alteration in people with Breast Cancer, run by Institut Paoli-Calmettes at 2 sites in France.
Trial summary
Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- molecular alteration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 749 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Dec 2010to 15 Jan 2026
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer
- age > 18
- signed informed consent
Who cannot join
- emergency
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Paoli Calmettes
Marseille, 13009
Hôpital Sainte-Musse
Toulon
About this study
Official title: Research of Predictive Clinical and Biological Parameters in Breast Cancer
Research of predictive clinical and biological factors in breast cancer :
genomic, proteomic, mutation
- Conditions
- Breast Cancer
- Being tested
- molecular alteration
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular alterationGenetic
research of molecular alteration
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | Experimental | blood and tumor sample Receives: Genetic: molecular alteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular alteration in breast cancer
gene expression level
Measured: average of 4 weeks after diagnosis
Secondary outcomes (1)
relation between molecular alteration and clinical and histological characteristics
hazard ratio between molecular alteration and clinical and histological characteristics
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study start22 Dec 2010
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Why it stopped: strategical decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole TARPIN, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521676
- Sponsor's protocol ID
- BC-BIO/IPC 2009-005
- Acronym
- BC-BIO
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2011
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Fattori S, Le Roy A, Houacine J, Robert L, Abes R, Gorvel L, Granjeaud S, Rouviere MS, Ben Amara A, Boucherit N, Tarpin C, Pakradouni J, Charafe-Jauffret E, Houvenaeghel G, Lambaudie E, Bertucci F, Rochigneux P, Goncalves A, Foussat A, Chretien AS, Olive D. CD25high Effector Regulatory T Cells Hamper Responses to PD-1 Blockade in Triple-Negative Breast Cancer. Cancer Res. 2023 Sep 15;83(18):3026-3044. doi: 10.1158/0008-5472.CAN-23-0613.
PubMed 37379438Fattori S, Gorvel L, Granjeaud S, Rochigneux P, Rouviere MS, Ben Amara A, Boucherit N, Paul M, Dauplat MM, Thomassin-Piana J, Paciencia-Gros M, Avenin M, Pakradouni J, Barrou J, Charafe-Jauffret E, Houvenaeghel G, Lambaudie E, Bertucci F, Goncalves A, Tarpin C, Nunes JA, Devillier R, Chretien AS, Olive D. Quantification of Immune Variables from Liquid Biopsy in Breast Cancer Patients Links Vdelta2+ gammadelta T Cell Alterations with Lymph Node Invasion. Cancers (Basel). 2021 Jan 25;13(3):441. doi: 10.3390/cancers13030441.
PubMed 33503843Guerin M, Eyraud R, Tsvetkov P, Finetti P, Giraudo A, Tarpin C, Hassin A, Bechlian D, Mamessier E, Pakradouni J, Boher JM, Goncalves A, Devred F, Bertucci F. The plasma nanoDSF denaturation profiles predict the presence of breast cancer. J Transl Med. 2025 Dec 5;24(1):197. doi: 10.1186/s12967-025-07499-8.
PubMed 41350712Guerin M, Goncalves A, Toiron Y, Baudelet E, Pophillat M, Granjeaud S, Fourquet P, Jacot W, Tarpin C, Sabatier R, Agavnian E, Finetti P, Adelaide J, Birnbaum D, Ginestier C, Charafe-Jauffret E, Viens P, Bertucci F, Borg JP, Camoin L. Development of parallel reaction monitoring (PRM)-based quantitative proteomics applied to HER2-Positive breast cancer. Oncotarget. 2018 Sep 18;9(73):33762-33777. doi: 10.18632/oncotarget.26031. eCollection 2018 Sep 18.
PubMed 30333908Goncalves A, Bertucci F, Guille A, Garnier S, Adelaide J, Carbuccia N, Cabaud O, Finetti P, Brunelle S, Piana G, Tomassin-Piana J, Paciencia M, Lambaudie E, Popovici C, Sabatier R, Tarpin C, Provansal M, Extra JM, Eisinger F, Sobol H, Viens P, Lopez M, Ginestier C, Charafe-Jauffret E, Chaffanet M, Birnbaum D. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study. Oncotarget. 2016 Nov 29;7(48):79428-79441. doi: 10.18632/oncotarget.12714.
PubMed 27765906
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Predictive Clinical and Biological Parameters in Breast Cancer
- ClinicalTrials.gov ID
- NCT01521676
- Acronym / sponsor ID
- BC-BIO / BC-BIO/IPC 2009-005
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: strategical decision
- Enrolment
- 749 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 22 Dec 2010 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 31 Jan 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.
Research of predictive clinical and biological factors in breast cancer :
genomic, proteomic, mutation
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer | Experimental | Genetic: molecular alterationblood and tumor sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- breast cancer
- age > 18
- signed informed consent
Key exclusion criteria (1 listed)
- emergency
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 |
|---|---|---|
| molecular alterationresearch of molecular alteration | Genetic | breast cancer |
Primary outcome
molecular alteration in breast cancer
Time frame: average of 4 weeks after diagnosis
gene expression level
1 secondary outcome
relation between molecular alteration and clinical and histological characteristics
Time frame: up to 3 years
Results and safety
The study was stopped early (reason given: strategical decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 37379438Fattori S, Le Roy A, Houacine J, Robert L, Abes R, Gorvel L, Granjeaud S, Rouviere MS, Ben Amara A, Boucherit N, Tarpin C, Pakradouni J, Charafe-Jauffret E, Houvenaeghel G, Lambaudie E, Bertucci F, Rochigneux P, Goncalves A, Foussat A, Chretien AS, Olive D. CD25high Effector Regulatory T Cells Hamper Responses to PD-1 Blockade in Triple-Negative Breast Cancer. Cancer Res. 2023 Sep 15;83(18):3026-3044. doi: 10.1158/0008-5472.CAN-23-0613.
- Results publication: PubMed 33503843Fattori S, Gorvel L, Granjeaud S, Rochigneux P, Rouviere MS, Ben Amara A, Boucherit N, Paul M, Dauplat MM, Thomassin-Piana J, Paciencia-Gros M, Avenin M, Pakradouni J, Barrou J, Charafe-Jauffret E, Houvenaeghel G, Lambaudie E, Bertucci F, Goncalves A, Tarpin C, Nunes JA, Devillier R, Chretien AS, Olive D. Quantification of Immune Variables from Liquid Biopsy in Breast Cancer Patients Links Vdelta2+ gammadelta T Cell Alterations with Lymph Node Invasion. Cancers (Basel). 2021 Jan 25;13(3):441. doi: 10.3390/cancers13030441.
- Results publication: PubMed 41350712Guerin M, Eyraud R, Tsvetkov P, Finetti P, Giraudo A, Tarpin C, Hassin A, Bechlian D, Mamessier E, Pakradouni J, Boher JM, Goncalves A, Devred F, Bertucci F. The plasma nanoDSF denaturation profiles predict the presence of breast cancer. J Transl Med. 2025 Dec 5;24(1):197. doi: 10.1186/s12967-025-07499-8.
- Results publication: PubMed 30333908Guerin M, Goncalves A, Toiron Y, Baudelet E, Pophillat M, Granjeaud S, Fourquet P, Jacot W, Tarpin C, Sabatier R, Agavnian E, Finetti P, Adelaide J, Birnbaum D, Ginestier C, Charafe-Jauffret E, Viens P, Bertucci F, Borg JP, Camoin L. Development of parallel reaction monitoring (PRM)-based quantitative proteomics applied to HER2-Positive breast cancer. Oncotarget. 2018 Sep 18;9(73):33762-33777. doi: 10.18632/oncotarget.26031. eCollection 2018 Sep 18.
- Results publication: PubMed 27765906Goncalves A, Bertucci F, Guille A, Garnier S, Adelaide J, Carbuccia N, Cabaud O, Finetti P, Brunelle S, Piana G, Tomassin-Piana J, Paciencia M, Lambaudie E, Popovici C, Sabatier R, Tarpin C, Provansal M, Extra JM, Eisinger F, Sobol H, Viens P, Lopez M, Ginestier C, Charafe-Jauffret E, Chaffanet M, Birnbaum D. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study. Oncotarget. 2016 Nov 29;7(48):79428-79441. doi: 10.18632/oncotarget.12714.
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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.
Carole TARPIN, MD principal investigator
Institut Paoli-Calmettes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing molecular alteration in people with Breast Cancer, run by Institut Paoli-Calmettes at 2 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 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 2 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.
Are results available for this study?
The study was stopped early (reason given: strategical decision). Results are not available in the source record.
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?
molecular alteration in breast cancer (time frame: average of 4 weeks after diagnosis). 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 NCT01521676, which also lists 5 linked publications.
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 21 Apr 2026.