Clinical trial · Interventional
Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer
Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study
NCT01460186CI-TRIAL-00036551StoRMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer. 1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed during at least 5 years every 6 months for 3 years then every year.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood samples
- interventionNames
- Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)
Primary outcomes (1)
- measure
- Germ line genetic factors associated with metastatic relapse
- timeFrame
- at the end of enrollment (2 years)
- description
- Genetic determinants that predispose to a metastatic relapse of brest cancer by establishing germ line genetic variation based on single nucleotide polymorphisms of patients with metastatic breast cancer and comparing this variation to a cohort of patients with localized breast cancer (SIGNAL study)(correlation between polymorphisms and risk of relapse)
Secondary outcomes (4)
- measure
- Genetic determinants that predispose to specific metastatic localizations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with a histologically proven breast adenocarcinoma, with metastatic progression diagnosed within one year (inclusion of patients who have a metastatic progression more than one year ago would favor the inclusion of patients with indolent cancer, possibly biasing the study) or locally advanced (no curative treatment) * ER, PR and HER2 status known * Age \>= 18 years * Affiliation with a social security scheme * Signed informed consent Exclusion Criteria: * Coexisting or other cancer diagnosed within the previous 5 years that may be responsible for the current metastasis * Patient who cannot follow medical surveillance due to geographical, social or psychological reasons * Patient included in the SIGNAL study
References
Publications (14)
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- BACKGROUNDVargo-Gogola T, Rosen JM. Modelling breast cancer: one size does not fit all. Nat Rev Cancer. 2007 Sep;7(9):659-72. doi: 10.1038/nrc2193. PMID 17721431
- BACKGROUNDAnsieau S, Bastid J, Doreau A, Morel AP, Bouchet BP, Thomas C, Fauvet F, Puisieux I, Doglioni C, Piccinin S, Maestro R, Voeltzel T, Selmi A, Valsesia-Wittmann S, Caron de Fromentel C, Puisieux A. Induction of EMT by twist proteins as a collateral effect of tumor-promoting inactivation of premature senescence. Cancer Cell. 2008 Jul 8;14(1):79-89. doi: 10.1016/j.ccr.2008.06.005. PMID 18598946
- BACKGROUNDRamshaw IA, Carlsen S, Wang HC, Badenoch-Jones P. The use of cell fusion to analyse factors involved in tumour cell metastasis. Int J Cancer. 1983 Oct 15;32(4):471-8. doi: 10.1002/ijc.2910320414. PMID 6684641
- BACKGROUNDTuck AB, Wilson SM, Chambers AF. ras transfection and expression does not induce progression from tumorigenicity to metastatic ability in mouse LTA cells. Clin Exp Metastasis. 1990 Sep-Oct;8(5):417-31. doi: 10.1007/BF00058153. PMID 1697227
- BACKGROUNDLifsted T, Le Voyer T, Williams M, Muller W, Klein-Szanto A, Buetow KH, Hunter KW. Identification of inbred mouse strains harboring genetic modifiers of mammary tumor age of onset and metastatic progression. Int J Cancer. 1998 Aug 12;77(4):640-4. doi: 10.1002/(sici)1097-0215(19980812)77:43.0.co;2-8. PMID 9679770
- BACKGROUNDUdler M, Pharoah PD. Germline genetic variation and breast cancer survival: prognostic and therapeutic implications. Future Oncol. 2007 Oct;3(5):491-5. doi: 10.2217/14796694.3.5.491. No abstract available.