Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer

NCT01460186 | Completed

• 1 other identifier: StoRM
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 17

Brief Summary

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

Breast Cancer; Metastasis

Keywords

Germ line polymorphisms

Outcome Measures

Primary Outcomes (1)

• Germ line genetic factors associated with metastatic relapse

  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)

  at the end of enrollment (2 years)

Secondary Outcomes (4)

• Genetic determinants that predispose to specific metastatic localizations

  at the end of enrollment (2 years)

• Genetic determinants that predispose to metastatic relapse of specific molecular subtype of breast cancer

  at the end of enrollment (2 years)

• Overall survival

  At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up)

• Progression free survival

  At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up)

Study Arms (1)

Blood samples

EXPERIMENTAL

Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)

Interventions

Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer) OTHER

Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study.

Blood samples

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ER, PR and HER2 status known
• Age \>= 18 years
• Affiliation with a social security scheme
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• Centre de Recherche en Cancérologie de Lyon: collaborator

Study Sites (17)

Hôpital Jean Minjoz - CHU Besançon

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33000, France

Location

Centre François Baclesse

Caen, 14000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Institut Daniel Hollard

Grenoble, 38028, France

Location

Hôpital Dupuytren

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Val d'Aurelle

Montpellier, 34000, France

Location

Centre Antoine Lacassagne

Nice, 06000, France

Location

Institut Curie

Paris, 75248, France

Location

Institut Jean Godinot

Reims, 51100, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (14)

• Sainsbury JR, Anderson TJ, Morgan DA, Dixon JM. ABC of breast diseases. Breast cancer. BMJ. 1994 Oct 29;309(6962):1150-3. doi: 10.1136/bmj.309.6962.1150. No abstract available.

  PMID: 7755703 BACKGROUND

• Vargo-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 BACKGROUND

• Ansieau 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 BACKGROUND

• Ramshaw 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 BACKGROUND

• Tuck 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 BACKGROUND

• Lifsted 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 BACKGROUND

• Udler 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.

  PMID: 17927512 BACKGROUND

• Hemminki K, Ji J, Forsti A, Sundquist J, Lenner P. Survival in breast cancer is familial. Breast Cancer Res Treat. 2008 Jul;110(1):177-82. doi: 10.1007/s10549-007-9692-7. Epub 2007 Aug 3.

  PMID: 17674192 BACKGROUND

• Cox A, Dunning AM, Garcia-Closas M, Balasubramanian S, Reed MW, Pooley KA, Scollen S, Baynes C, Ponder BA, Chanock S, Lissowska J, Brinton L, Peplonska B, Southey MC, Hopper JL, McCredie MR, Giles GG, Fletcher O, Johnson N, dos Santos Silva I, Gibson L, Bojesen SE, Nordestgaard BG, Axelsson CK, Torres D, Hamann U, Justenhoven C, Brauch H, Chang-Claude J, Kropp S, Risch A, Wang-Gohrke S, Schurmann P, Bogdanova N, Dork T, Fagerholm R, Aaltonen K, Blomqvist C, Nevanlinna H, Seal S, Renwick A, Stratton MR, Rahman N, Sangrajrang S, Hughes D, Odefrey F, Brennan P, Spurdle AB, Chenevix-Trench G; Kathleen Cunningham Foundation Consortium for Research into Familial Breast Cancer; Beesley J, Mannermaa A, Hartikainen J, Kataja V, Kosma VM, Couch FJ, Olson JE, Goode EL, Broeks A, Schmidt MK, Hogervorst FB, Van't Veer LJ, Kang D, Yoo KY, Noh DY, Ahn SH, Wedren S, Hall P, Low YL, Liu J, Milne RL, Ribas G, Gonzalez-Neira A, Benitez J, Sigurdson AJ, Stredrick DL, Alexander BH, Struewing JP, Pharoah PD, Easton DF; Breast Cancer Association Consortium. A common coding variant in CASP8 is associated with breast cancer risk. Nat Genet. 2007 Mar;39(3):352-8. doi: 10.1038/ng1981. Epub 2007 Feb 11.

  PMID: 17293864 BACKGROUND

• Thomas G, Jacobs KB, Kraft P, Yeager M, Wacholder S, Cox DG, Hankinson SE, Hutchinson A, Wang Z, Yu K, Chatterjee N, Garcia-Closas M, Gonzalez-Bosquet J, Prokunina-Olsson L, Orr N, Willett WC, Colditz GA, Ziegler RG, Berg CD, Buys SS, McCarty CA, Feigelson HS, Calle EE, Thun MJ, Diver R, Prentice R, Jackson R, Kooperberg C, Chlebowski R, Lissowska J, Peplonska B, Brinton LA, Sigurdson A, Doody M, Bhatti P, Alexander BH, Buring J, Lee IM, Vatten LJ, Hveem K, Kumle M, Hayes RB, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hunter DJ. A multistage genome-wide association study in breast cancer identifies two new risk alleles at 1p11.2 and 14q24.1 (RAD51L1). Nat Genet. 2009 May;41(5):579-84. doi: 10.1038/ng.353. Epub 2009 Mar 29.

  PMID: 19330030 BACKGROUND

• Lander ES, Linton LM, Birren B, Nusbaum C, Zody MC, Baldwin J, Devon K, Dewar K, Doyle M, FitzHugh W, Funke R, Gage D, Harris K, Heaford A, Howland J, Kann L, Lehoczky J, LeVine R, McEwan P, McKernan K, Meldrim J, Mesirov JP, Miranda C, Morris W, Naylor J, Raymond C, Rosetti M, Santos R, Sheridan A, Sougnez C, Stange-Thomann Y, Stojanovic N, Subramanian A, Wyman D, Rogers J, Sulston J, Ainscough R, Beck S, Bentley D, Burton J, Clee C, Carter N, Coulson A, Deadman R, Deloukas P, Dunham A, Dunham I, Durbin R, French L, Grafham D, Gregory S, Hubbard T, Humphray S, Hunt A, Jones M, Lloyd C, McMurray A, Matthews L, Mercer S, Milne S, Mullikin JC, Mungall A, Plumb R, Ross M, Shownkeen R, Sims S, Waterston RH, Wilson RK, Hillier LW, McPherson JD, Marra MA, Mardis ER, Fulton LA, Chinwalla AT, Pepin KH, Gish WR, Chissoe SL, Wendl MC, Delehaunty KD, Miner TL, Delehaunty A, Kramer JB, Cook LL, Fulton RS, Johnson DL, Minx PJ, Clifton SW, Hawkins T, Branscomb E, Predki P, Richardson P, Wenning S, Slezak T, Doggett N, Cheng JF, Olsen A, Lucas S, Elkin C, Uberbacher E, Frazier M, Gibbs RA, Muzny DM, Scherer SE, Bouck JB, Sodergren EJ, Worley KC, Rives CM, Gorrell JH, Metzker ML, Naylor SL, Kucherlapati RS, Nelson DL, Weinstock GM, Sakaki Y, Fujiyama A, Hattori M, Yada T, Toyoda A, Itoh T, Kawagoe C, Watanabe H, Totoki Y, Taylor T, Weissenbach J, Heilig R, Saurin W, Artiguenave F, Brottier P, Bruls T, Pelletier E, Robert C, Wincker P, Smith DR, Doucette-Stamm L, Rubenfield M, Weinstock K, Lee HM, Dubois J, Rosenthal A, Platzer M, Nyakatura G, Taudien S, Rump A, Yang H, Yu J, Wang J, Huang G, Gu J, Hood L, Rowen L, Madan A, Qin S, Davis RW, Federspiel NA, Abola AP, Proctor MJ, Myers RM, Schmutz J, Dickson M, Grimwood J, Cox DR, Olson MV, Kaul R, Raymond C, Shimizu N, Kawasaki K, Minoshima S, Evans GA, Athanasiou M, Schultz R, Roe BA, Chen F, Pan H, Ramser J, Lehrach H, Reinhardt R, McCombie WR, de la Bastide M, Dedhia N, Blocker H, Hornischer K, Nordsiek G, Agarwala R, Aravind L, Bailey JA, Bateman A, Batzoglou S, Birney E, Bork P, Brown DG, Burge CB, Cerutti L, Chen HC, Church D, Clamp M, Copley RR, Doerks T, Eddy SR, Eichler EE, Furey TS, Galagan J, Gilbert JG, Harmon C, Hayashizaki Y, Haussler D, Hermjakob H, Hokamp K, Jang W, Johnson LS, Jones TA, Kasif S, Kaspryzk A, Kennedy S, Kent WJ, Kitts P, Koonin EV, Korf I, Kulp D, Lancet D, Lowe TM, McLysaght A, Mikkelsen T, Moran JV, Mulder N, Pollara VJ, Ponting CP, Schuler G, Schultz J, Slater G, Smit AF, Stupka E, Szustakowki J, Thierry-Mieg D, Thierry-Mieg J, Wagner L, Wallis J, Wheeler R, Williams A, Wolf YI, Wolfe KH, Yang SP, Yeh RF, Collins F, Guyer MS, Peterson J, Felsenfeld A, Wetterstrand KA, Patrinos A, Morgan MJ, de Jong P, Catanese JJ, Osoegawa K, Shizuya H, Choi S, Chen YJ, Szustakowki J; International Human Genome Sequencing Consortium. Initial sequencing and analysis of the human genome. Nature. 2001 Feb 15;409(6822):860-921. doi: 10.1038/35057062.

  PMID: 11237011 BACKGROUND

• Olivier M, Aggarwal A, Allen J, Almendras AA, Bajorek ES, Beasley EM, Brady SD, Bushard JM, Bustos VI, Chu A, Chung TR, De Witte A, Denys ME, Dominguez R, Fang NY, Foster BD, Freudenberg RW, Hadley D, Hamilton LR, Jeffrey TJ, Kelly L, Lazzeroni L, Levy MR, Lewis SC, Liu X, Lopez FJ, Louie B, Marquis JP, Martinez RA, Matsuura MK, Misherghi NS, Norton JA, Olshen A, Perkins SM, Perou AJ, Piercy C, Piercy M, Qin F, Reif T, Sheppard K, Shokoohi V, Smick GA, Sun WL, Stewart EA, Fernando J, Tejeda, Tran NM, Trejo T, Vo NT, Yan SC, Zierten DL, Zhao S, Sachidanandam R, Trask BJ, Myers RM, Cox DR. A high-resolution radiation hybrid map of the human genome draft sequence. Science. 2001 Feb 16;291(5507):1298-302. doi: 10.1126/science.1057437.

  PMID: 11181994 BACKGROUND

• Azzato EM, Pharoah PD, Harrington P, Easton DF, Greenberg D, Caporaso NE, Chanock SJ, Hoover RN, Thomas G, Hunter DJ, Kraft P. A genome-wide association study of prognosis in breast cancer. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1140-3. doi: 10.1158/1055-9965.EPI-10-0085. Epub 2010 Mar 23.

  PMID: 20332263 BACKGROUND

• Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. doi: 10.1086/519795. Epub 2007 Jul 25.

  PMID: 17701901 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Blood Specimen Collection; Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Thomas BACHELOT, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: October 26, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

FR (17)