Clinical trial: NCT00634634
Section: Alternatives
Subsections: ()Tlirr Ll Erl Icr Tions Or Su Llplrnrents|What Arc Mv :Rlternaiives If I Rttn'T N,An( Trr L Rtir:I Te In Thi.S Litudr,Y

Ph*sc I  
  
  
lI  
  
ine l'hempy in li\rsfirer.:c;ruusal Wonren wilh Itarrr bul rrrious sidr effccts iuu:
',,1jlurgie r*il{lit}lti, ilrulnrirr:r srv*liirrS
. A:tit1:lt;' l;.rctic shocL, ; \1(1.\ s,.:\,crt: lllur.uii
('tCCilt't'Ct.i.  
r(:il(:til)lt {hrl cirn ci)tlsr: dcath is quitc rarc, but h.K
l1':rtrr'of tlre.se st'ril|touis rrctrlr. plc;l.rc cril -r,c,ur slu{ll clr,,.:trrr irn,rr:criatelr,.at
"I'ht risk's itssttciatetl with a c"l'sctn o ia cornput,:rizeel picrur.c to loc{ltc *nd n:casure your tumor); [)iscur,fbrt or arxiety lvhen rying insitre the ci s{*rrrer
' 'lhe cunirusl material (tlyc) is injccted anrl nray cnus$ vorr to get 11 nrerallic taste in .your mouth r You nray fcr:l rvarrn antl rur*ry ({rusc *i}il$ea ur vurrili*g r You will be expr'rsed to sonle radiation rhrough tlrix procedure. 'l'here is always a slight risk of 6arnage from bcing exposecl lil anv r*diation, includiilg thu low alnounts ul'x-rays usecl lbr the cT scan. If y*u ar* especi*lly concenl*d rvith rlclialion *xprlsur*. please rliscus"s thi.s with yuur drrctor.  
Whcn your hlrrul it elri,rwn rhere ii l posxibility thrr ciiscoloration. .r (mrely) i*fccti<1, at the pkci: *l:e.e y,.,r there nriry he slight pain. a hruise, hlccding, bl,"rod is dnrr,vn.  
tluctr'rrlinr,cstipirtor lrlrrl pcrnrissiorr rs {ilcrr lo c111r11,.,,,* ttrkirrg (h{":sd ttlirdi{ilrfs.  
otlrcr rluclrrrs l:irrr_' llrrsr.rr[:cil fi:r I.rirr.  
.r\lso,grapefruitorgr:r1ltfruir.iuir:e  
  
,"p.ri-i, .,' e;;&;; !rr! 'rirvJ. r s{rrrx $rdF}srt ulr uI. srilpclrutt j;\# Julcl3 ;;il;.*r hccausc it nluy itl'fu:t:l hou'ynur hucly ahsorhs th* rncrlieatir:n.-Tlris could h::t ti,n littlu r:r truo rnuch crl'llrc nrcilication into yttltr botly uncl n(rt allow the nredication ti; rvu^k as it is suppt-rsrtl t* Prt;lt I l tf'19 l'itirru I
I lrrr PI:
trst-1 .irtr: I lirrap.l, i:r Poilrrrr:rttllarrsaI \\.rntrren u,ith lll crt'

Yrur study d*ctor is willing 1o di5.r,*.* t1.,., bcrellt-s tnd sid* cllbuts ol'*th*r tirrrns ol'lr*atrncn{s otlrcr than rhis that are avuilatrlr. 'l"hese inulrrilr L)ther r:sua'l hormunal ther*py ti;r,'*our lype of canerrr, which may ircludc lhe same hormqnnl therapy that is us*d i, this stud3' *r e:lher rr*rgs ^such as tarnerxilln.  
rocliali*n thcrapy. tx. ns\ry anli-canccr
)(r.(rr.,r! lvt .lllUl ltlll:
Yurt l)i]\' ulst: uhrtrsr no tlrtlr,-:r freitUlletlt. rvith uarr: unrl rnci!icines to ireli: -vou lccl murc clnr fi'rnirlrh:
(lthcl cxperirnentnl slrjilits tritlt cir(:nr,illrir:.or.l . hirrrrtrlltcs.  
irg(rllts tha( rtriiv I.rc ur.ail:rbl,": lilr \,our tlis(fll$t),
illease feel fiee ttr discttss these nther *ptions with vour clrutor ancl ask any question$ yilu may have. Take as much time fis you need to make yixrr clerision"
Clinical trial: NCT00634634
Section: Confidentiality
Subsections: Ii,W Rvill Lny Infirrrn*Tiuu Rrt Kept Pri'Urr Rnd C,Ntitrtrntirrl

ry.Il]i],Tliii;]:l;i:lili,jl,l.I;]]i,;.:;n:;llxlihi:::;:,*ff,I];j,:l,:lli;;,r:J*.r.-
:_Tj:Tl,:".(:1.:.r]:, ]""-riats rtcriveit liom ytur sarxpte{s} wilt be given a co<te numher and storod in a password-pretcctcd seuurcd dntabase. I hcsc rpassword-pmtcctecl with dntabases are h.lcatccl on securcd $ervers lirnite<l ficr:es.c h), ke!,iitlxlv flcrs(1nnrl. (irrl-l infirrrri;rriirrn lrlated tu y{}ur di;rgrrtsis will he linked uitlr not ::il1t:::;;3.ii:,1i;, il:ifill::'tl}::illili,l'ffixl:xfilIi,:1il'[;t;;il],['l],ll;l,;[jl,Ti| he accessii;le tr s11t,rrr* besidr:l gl1)rrl't I'his basic rescire Il is uul irttcnclqd tr:i $ir''u vou clitrieal infirrmntion. You untlerstand anti agree that you will not trc l0lel alrout your inr'liviclual rcs,:urch results. Irr{irrrrrutitu resulting fi.n1 1fu;, rsssarch will not bu entcrccl ittto yeiur rneilital rei:ilrd, Neither )i{.ru. nor your Iarnily nrembrrs, nor outsi6e parties 'r the stutly doctor rt'iil be lrhlc tn k:ok irt vtur iniliviilrral n:search resuJts. It is po.ssible, however, thal membcrs ol'
:-t,lll',1',,'H-;: ;\#,n' ff ,1; ;l,ll}'l-',, ,i,];,f,t', Jff ll iil : *Ht I:H:,J*I* fi [i:, the significurrcu ul"tlrc l*tr0ra(orl: ,*r*r,,,*l.,. nr will n$t usc thesc rcsults to rniln{ige -vour nredical core.  
wh*t are my rights il'I agr*e to the use of rn1'bltod/tissue firr oth{rr fypts of rexearch or for gcnetic trsting firr futurc rcscarch?  
Yrtu underslattd thnt yotl ltitr"e the rigrhr to ask iiues{ierrrs uhtut -ynnr hloorulissue samplus {rt imy tim$.  
Who rnay'give consclrt to par.Xicipate in this stutlyl, 1'he invesri5lator i's itrlcr**lerj in tirriing nr.rt if yr:u clrn firlly nild*r$riind rhc iul:r.r,ation thar h*s been given so yoll (:{u1 {:l}t*r irrto tiris stud-r'' You x'ill bt lolci il"your ilinrss has allucled your r:bility tCI give consent feir  
  
  
  
Pher* lrll r,ar''rl t''o''"*f,tlt':*I'*t;il,t[',1,1;:l;l
"'. ih*r';,pv rn p.${,,*rerp:i*sar wo*rrn r,virh [,'ryryf",'",
your h,,gallv autlrorizrtl llcrsrln n,hr, u)l_\.rrrirkr: tirrr.iqcisi,-,,rt lbr l,*tr.  
cottrphlr:,.i vr,lLrr p;lrf iuipirtion ilt lhrr \tLt{i\,.  
['hC slLttl\,"ioctor's i.t]iSC.t.stl]Cttt crl l.trrrr tupile if1 1o c\1il]L:ltI t(] r.'olunlet:riltg iirr {lris rtt*ilr(:l) Sltrrlrr It riocs t.tol itrisc.{s viluf sLrelt as linarte itrl" ir:t;rl. ilrrl,,or ltr{:,(iiL.irl rler.: isinrrs.  
rnter inlc) this r-esearch stuily only applies re .l,ou ca;raeity to milk* <Jccisiuns f<rr crihcr pu{x}${rs t\#hat src m) riglrrs if I deciqre to parrirripatr in this reserrrh sfutly? You have the right to ask quesrio*s concerring any part *f th., srudy at any tinie, fi:rnrr unl*xs ytu havc h;rtl a chnncfl t() alsk {u{liitions rilrclrecejve ttn$wcrs to nll ol, You slrould nut sign rhis youl qussli()tls.  
i hlue rr"aij tlris rrrtir* firrnt. or it hlrr lrt:,-,rr r.elrcl to nrc.;rrrrl I hgllc1,6 rl,tar I ulrcier.stltntl rvhat has hccrr in tliis researcJr stlldv il*d h*ve hce, gi.,c, a cr)py rl, this u.rr.rr*t, l)atient \une.  
P*tient Signature Datu:
'l'erl continrrr;d on nrxt trlagr t'rgcI"r'fi9  
  
  
  
  
l'h,rsr l,'l I I'r"ia] ol' l.etr.ozr ftil;:; ;lli;1t;l r,];l::,,,. i r*ra1,r' i n',,s,r,r,,p,.ira r w.rnrn rvi,ri
Clinical trial: NCT00634634
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: \Ylrat Are Tlre Risk.S Llrrd,Iul" Tlisr.Ornforts I Chosr Ltr In This .Rturlv?|Specific Side Llffccts Of Fiaeh Drus: Snrufirnib|Ll* R{.Br*Pcrio Us *Dc.L{Sct! Arc:|I Lrc Tnusf Conrrnon Sidr Efj'Erts Alc:|Itarc Hut Scriuus Sitk Lffcct-R Alc:|L'Lrc Most Colnmon Sidc Ul'Fccts Are :|(Jth*R Lrss Colnnlon Sirlc Ef'Lbc(S Lr.*:

$Jenctql Ri{ks:
lf you decide to tnke f)flI'l i,t thrs study. you urdcrstand that you moy take the risk of'thi.t
$ffective against y()ur ililn$er. The clrugs used in this slucly ,i,o,o *oun* all, nune, or liurne e{ftcls Iistccl" A}so, there is alr.vays tfr* risk ut'dcvcluping very rulcornmor} or previgusly eflbcts''l'he risk of trsinl; tlresc clrugs in c*rnbinatiunls rieit kno*.n ar this tin:e.  
trciltment not b*ing o{' the lbllor.ving sirlc runknor.vn side

Snrstbrrib is an invcstitillionnl tl'ttg stuilictJ tirr use in hiirmr.rnc r'*ccpt{}r-pri.sitiye aiiva,ced or rnetaslfltic l:rcast citr)cct .  
"l'he most e()mrrotr sitlr rl'l'ctts *rrr:
. ltctlttcss ilt(i,'or -.r.r,ullir:rl ll'tirc lr;.urtls anrl/or tcct
. Skirt rirslr
. Flrtiguc (ii surrirtion ol'ltclirrg overly lircd or slcr:p},and lackirrg irr cnrrg_v)
C:AUTI{)N n*oT},: tlu ttot drise or operate;l}r.y- machiner3'il'you rrc l".,li,rS uverl"v- tiretl ur slcup.r,'.  
' l)iardlcn * irre tuitsctl li'r-:tlutrtrl'rrf'hr.rlvcl ntovcnlcl)l$ r,r,ith ful*sc. lqtrlcry st6rls
(.)tlrcr kss c{t}nrn{}n sirJt cflt'r:ts ar*.  
, ,,\n irrcr*asc in i:ltird lll.rsslrre
. .,\ lk.et-r.:rst' ttt lryr1rt,li11,
. \Vtight ltrrs
. Chills
. Icver
. P:.rirr irr I r:ur jrriril.,
. I)nirt irt 1t:rlr nltrs{lr.r5
. AllcrSie tcllctir.lt)s (rr lltc nlL'(llc.rtit.rrr
. I,lu-likc .\l nl11t1)|t)s
. l'lirslrin$l rtl'yrrit:" iilcc ilndror ileck
. Iligh [:lrcrl suLrar' {dirhcri:s}
' ,'\ ilccrrasc itt thr-: prtrtcitt lcr,cls in yr>rlr bluod thal cau carrse tluirl rctenti(,ri
' ;\ tlrcrelst in titt plt0s|ltntr: ltvcls in vollr hlrrr-rel thnt cart ltili:ct -1,utr htin{:s. t-rtrr*cles. iteart unrl It*rvQil$ $)'stcnl
. II*ir lirirrrrirrg {)} i}atcll-v luir ioss
. ('rnching {}r Il{:{linlt ul'sIin on lrlrrds tr li:'ct
. Dr) skin  
  
  
  
  
a a
,
a I
a t I
a a a a a a a a a i I
e I
t lout dev*loprncnt nf'uncven potehss ol'y*riuus size rhnt j;:fi],1,1,:,:;J,;i,.;111'"' '8,1111: rtlr:rr1r;r'f . i ir.r,r i,r.'rhr.,ri,yrr irr 'i,"i,,r.,,rp,iLrs:rr
!\,,r:,r.ri *,i,rr rltchinp Ar:ne
{'halrg.cs rn thc xrils i)l \ri\ru. linp.err..s ;}lirl/i}r. l
(' lr ang.t:r i ri llte r: t.r i r,rr- t{.rrls lylr _1,,11rr sli ir i u,i tlr al r' laul, irrg ilr ctrk rr Nrrn-li lt lhrelrk:nirrg sk irr c;l.lL:ctr, A bdi.r nr irrirl ;:r,ri n
[ :pset. sti)rrtur:ll Ji l llerr] tr rl i gus{.irrg lircrl I leart hulrr
\ituseit tl,":1li11U lis il'\lirr'r.c 1hqr1t to lhr6u,-ypi V*nr i r ilrg { tilrur.virrg-up.}
ill.ssincsr tiucrelisu- in be lchirrg andior pnssirrg girs)
(.'rr*.sti pirti on { rl i f}r crrl tr. }rav i r: g b.rvc I rrr*vr,rcrrts)
Ahdorlin,rl s*,elling rtrle to ;r lruilrl up ol.fiuid irr 1,our.hi:lly lntesti rral hlr:riliut Dehvilrution S0res irt th'-: lirling tll'\'ttttl'ntrirrth lnLl/lr thrnnt liral i-:an rltrke il rlitficrrlt {,,:^,rvnll*w r\ decrr::h* ili thc ttuttrbtrf ul t(riJ l:ltioclcclls.'l'h.is can nraku you l*ql tired clr r.lerk, or )r1,. *rily hltUe 'silttlr difilcrrlr\. br*ltltiltg. I['t'lre clecr*nsc is sr:ver*, r,.,r, rrrfly lrreri a triurslusir.rr er{ rccl [rklrlrt cr":lls.  
A dect'r:rits* irt ilic rruntllcr ul'r'r'trittr hlurrrl crclls."l'his rnlv.lor.lsc nn infr:r,tirrr sinc* *,hilc bl,:od cclls he lp tu l'ighl inl,uuriorrs.  
A rlcct'cits': itt ihc lltttltbcr ul ;:latelets. lhi.s cilri cl.rLrse \()u [o lrrrrrse eusilr.or 1o lricecl rrrorr tir.sil' as plittclt'l: ,;trt itttirorlitrrt lirr ntaking t lotid tlors. lf'thc riccre.'rsc is scvcrc. or
'r1u lravc hlcccling.  
) oll nlu\ tirrr(l ir tr;rrrslirsill: rt l'plale lrrls_
L)lttltilge to \rotll nLrr\ics lltitt rlltrt.rcs the lcelirrg nl'pins rnd rrec,*lles irr !rrur hands. ling*r.s. leet and toe s.  
l)lnutglr l{) \.r)ur pitnt:r'cit_\ (llris r:nn cirusr:1xrin. llaltJ{(:it nnil r,*rtitittgl I)lnl:tglc kr ll1.' 11t- ',' t','itli itlrtt*rtnalitics in hloutl toiits lhfit nleirsrlre thc ljr..er's nr*rlal lir,trtiurr ('ouglr
.\ btrild rrp rrt'f)rrirl ol'r.our r.ircxl catrit.r, th;ll tr;:n n)tktt yorl li:i:l slrr.lrl ul.brr:uth ;\r: irrllrrrrilrirli{}n r}l'.\,rrur lunts thut rliur uukr yuu l*r:l shlrrt ol.hrr.rtl-l l-trrrg u,:llaylsc lr lLrgirur( (llat erir hr: lii* tlleatcnirrg, Illttdilri: lj'olu \rrul rrli rrlfr irirt:tilrllrgtl irt yt.rttt^trrinc K itlricv dlrrrirgr .:irid,/i) r. I ai I rri,:
I)cpre ssilrr Plge I ul'l!  
  
  
  
I ;i V*nion lli.rtei (}l,'l.il ri"rr I l.i
' ritr, l, &FIlrE#VilS

the bou'cl ()l.r'i()li)llcli lr.il:itrilitlt( tinai tracl) tirat r:raj, rcr(lrlird surglrr' trl re;:lrir irrr,.l can hc lilb t lil citlct t ing { \:{rri n ti.t_y I }i} r,t: 59 1,g1.s stni ltar_r I r lla.irt) ltlci:tlinS tutit litt": brlirr r:r sprn:rl corit 1,1'1111 r:r1y llti,c naLlsr$. \irtx)itiJtS: ir..arjuche: llrss tl. t{)rtrc iou sr}c ss. si rrrrr:il spur:clr. pa:.llvsi s; If any ol'thi:se .syrnpk)rrls occur, please call your stuely cluctur imm.rrji*tply at srtraleni [: r:;uses lherrr.  
' .litint srveJling an,.l r.drhress
. Arrn rlr k:g sr.l'clling
' Ini;:rcitscrl risk oi q*rr{
. Irrte.tlirurlblorkeqc
, ll;tck p;iin
. llcing 11,,1,,
' ("lrr.st ir1'lilr P;1i11
. ll*ildurlrc r r\nlt r-rr lcg parrr
. Bluuil i" luts
. {'huriLtes ir"r vtrrrr l'}unLinc ^s--\sleul Llral c:u.t 1-rut vou af risk ril"in]cctillt
. Strokr
' ('hrrrges irr lrlrr<rtl r:lrlfiin5l lrr,pcrticsl *rir!,ir)xrcrst-r risli *l
. l)izzincsr
. I.ee linH liglrrhcltlcri or tlirrrinl r Anxi(:t)'. ll(11'\'()usilrss r l-os$ rr l fitertror-r'
. \,lcutirl irrrpirirurclrt {coullsioril
. lrrcsLrliir nr fitsl lrr.:irrt lrcitt
" Il*art tltu'":k
. I leart lirilLrlc r []lcrtlitre irr th,,'iurrgs and tht: r:hest r Stl!'crr lt;rrg inirrr-v
. I-.r('t'L(iliesi rriih p.rirr
. l)ottbl,: visrltr
. Slllrcrr drnragr
. l'rr*ling ill thl' skin
. l,(rlv l1:t,r:ls r.rl sr.riliLrrn irt vriur l:lood hrlrm{irl hler:ding or clouing l,i:,,ffi,.,',t,".,.iffi1r,..;lt,il1.,,,\.1":,.ni.,ti'l.t,Il5l{.':t|ti'i.'t,  
  
IJ;l{ir il al it)
: I illl-1"-ittr: 'l'1r*rap,,, ir) frltatrlcl(ri).r1strl \l,6itten llillr
;. l;urrtf a
\ioitr.: cliililgc$
I-.r'r":rti lr"r,.l.t, r I irrre t i trrr a Lqtrozole L,ctroz"ol* is an upprovud trsatnl$ltt lirr hornrone rrcep{ur-po;itir,t: uelvsrt:rd or ntsl$st*ri* hreast cancer.  
t a a I
a a t a 0ther a I
1.  
a a a Irss 1;urrrrrr,rn sidtr rl'l'ech lrrr.  
I )i l'llrrrlrl slr.rr'pins Llcprcssirrn I r rcrcu.s,,:r-l h k ro,"i g:russ r.r r.u lliurrltc*
( ltlr t.ct illr iorr N;rtts,":ir l.i.rss rrf el)l1f tite Ahdorninal frrin lJunr: lilr:lurc a a a  
```
ll':ictulcs.
Ilror.vsirrrrs
i\luscle uches
a
I

```  
l)::g-r'9 rii lil

\\ictk rtr-:ss or i l*t ie:rs*d ultcr.i,ll I Iut lllshesi'J ] uslt,.:s Irr,":rcasetl cirul cstr:ru I l c r,,c l.s Illi:rr:asr:rl sryt'rtl i n q Sllcliirrg in thc irantls or feel
('r,nslipatiorr Dizz-.in,"rss l lcnriilcht
('lrcst ;raiu a
. Jointp&in1s1lfli1*s5
' [-{air loss or thiuning
. Bune pain
. Illack puin
' Shortne ss ol'brcath
. Cn*gh
,t::;x.::'lxim;,.|];::j,,-l,iierrrp1.ini}trslrnettrrpiltrsalWnrrrurrwith Plrir.le ltll I rial ol'l.crruzole a Vagin*l bleecling  
  
Vagin*l dryrrcss a

ill'()hlet'lls r.rlrile iirkirr* ltrlr.r:zolc rvlr sirrriltrr irr ll)u lrt::.rtrrlatc of rl,rlr1icrt rr:.:cir,i1g, lirnrpsilurr, r.vlticli u'illt u'ourctr t0king letruzolc ls rvith \\iot])(ti tahing a plrcrtrr.r (a piil lhat conrairrs uo acriVe dnrgsi.  
hr lissnciirlerl with it yer-y srrrall incrcasr: ir: risk. r llldr)d clot in I b|1111r1 \,cs.!trl

. [ {r:t tlashes
. l)ccrrasc in.rc.r dr,ir,c
. \r*ginirl .Jryircss irrrd.ror d1-.sparcunil { pairrllrl ir:rurcrtrrsc)
Stopping ol'menstrual periods atrd tltc inatrility to lnvg chiklren r.vhile rucsiving the injeeticns are ilesirecl elfects of' these nredicati ons

. I le*thclrr:
. Iirq,.lness
. l)izrirrtr.ss
. hiotlii cltirrrr.,r-ls
. Slecp ilislurlrlnce
. ,r-ausca
. \irltnililtl:
. [.0ss rit apfrtrtr
, lllruk *r..ioint ririn
. I r:elrl in'i tirli(ut x,herc the shrrts lrre uir rrr
. [.,t'rss trl borrc litirrcr.iil durrrit-i, ir:sicoportisis) nlily (lui:ur *nci r:ray lead ttr hrerkcn hones lt;::r: lii,,i il)
Clinical trial: NCT00634634
Section: Procedures
Subsections: )Vha( Nill I Br: Askt:R! Lo Tlo Il'L Lrartiri Trr In Thi.S Rescar-Ch Studt,?

flefore you may takr part ir ions and have the firllowing tests antl cxaminations cxilmtnallons to stc ilf 1'ou art: t:ligihlc. 'I'hi"s is callsd screening. it is imp*rtant thar you a*swcr all questions honcstlyattcl ctlm;rletely, I)cpcnding iln li:e ansr,ters t* thesc urreslionr nnrl rh, rnqrlrc,rf tr.ric qs.rr I)cpcneling on ti:e ilns\vers tfi thesc queslions and the r**uit, r:f test.cand cxanunalions. it is possihle thut ynu nlily no( he ahle to take part in thc sturiy.  
In somc instances. certailt tests or pror:eilttres c*nclucteel <luring thr: study nray havtl to he repearerl. lhis ur, happen il'some orall of'the results nru unusahlc. Alsr:, yn,, **y be a.$ked to havs ad4ition*l re.sts or exanlinations. I'his call luppen ilatr unc.tpcclrd nrsdieal cvenioceurs tluring the stucly.  
Before you hegin treatntcnt, you will trr:ccl to lravc thc lblluvilg tusts gnd proccilurr:s tli:nc:
. A history anil phy.sicul rxant.  
' You will be asked {ht:ut the exlent ol'your physical nctivity ancl how you are generally leeling.  
. Your wcight antl huight rvill hc rakcn,
' You will have hlo*d drawtt usirtg a small needle or pla.rtic tuhe, In check ynur hlnocl cgunt.$, your blood chernisrry, urcl ll*w 1,rur livcr a*d kidneys are working l',tirr: i l1 I't H(rrilltlne pt lllrsre l,'l I Trial r:f l,etr*zoi*
'f'"'{: s{}r.'rtL'lr ,,f l* i"ir':.t.1 rrrt, ilrr.ra|r.ir) l).rtr}r*rrr:rr;.lr:.ril \\!)rir,,.\rrii l..,,rt.rJlr .\rji ;ir,i,.rj or' [,1r.t.i::iiil ir"r l.lr..:rll (':rneci.  
You will h*ve an gl*ctrocardiogram clone (alsrr kn*rvrr as
.,1
). l his is u painhxs paper tracing o{'y$ur heart's non.nill e lectrical $ctiyity.  
If'your dCIclor fbels you ri{rd }t, yDLl $l{ry rinvu t. have a (.A
look at thc orilans in -1,t:ul. bocly).  
['scan or lr,lI{.1 (spccitl tr:sls which Ilal'iiil;rble. ll \ar*ill* i)l'thr tissr:* urken lrorn the hinpsr, r:rl'yurlr{rinlr)r.tnken at the tinre ,f your original diagnosis rv.ill hi.: r'*quc${ed l}om the d*ctonui,r, p*.ii,.ruc6 the hriupsy. 'l"hc turnor w*ill lx studied to sce lile l:takc-rtp ol'cellatitt ecll.:. u,hiuir rtra.y,nak* $rlmg (imcsrs responcl to this tre&ilnerlr. Yor rniry nr:t <iirectly @g,trr fi.nr th(rsc Iests. (Filrt'f lr.ese'rrhi It'you itre * Iclier:t filIlou rvill ulso be askerl to have blood drawn usi,g a smalJ neetlle or plustic titlx' Lt 'stn|c lirr lllttrc tr:sting. lt is nur kriurvrr at this tirr:r: what thesc tests ruay bc. Ahort l lablespoons of'r'tir-tr blci;rcl rvill he ustrl lbr tlrcscr tcsts. "l hese serrnples arr opli$ll*1, il'yclu cio ncl agrcc to thcsc adtlirional sarnples. y()u mav still raku part in the study. (part 1tf Rc*rarch) You ttlltl' Lre asked to ltitve l-'itry:sies ( removal nl'small iirru. saniple fiunr the lrca wherc your ilixu,s* ,dlffi ffii ir';. ;-rxll,:ifixriili i*y ytlu do n()t flllre* to thesur adclition*l sampks, you ili liifin ffi nralr still take parl in this study. (part of Rcsrarth; You r'vill haYe blurd drarvt: u-sinlt a snlall ncedle ri plastic trrhe ro c:hcck circulating tumor cclls {crcsj priru'to tx:gir:ning the rriar nrd arierr I cy*res of trEatrnent {at g weeks} (..[cs can he {huncr in the hloorl il{'pirtients rvir}r a r.alictY ot'nrclrst*tic carcinomas and recont resilarch has shown thnt the ptrscrtee ol-Cl'l(l's cilrl potcrrlliulll'[rr; us,:d to prudit:t lrorv patirn{s r,vitJr nreterrtatir: hreas(uauccr will cit: r,r,ith cr:rtain ntr:riicatirins. (llrrl of Research)
TrSa!ryrent Plsn:
If you decide to t*ke part in this slud"v and arr: ahlu to join b*sed un the above criteria, y*u will have the lollowing treatmcnt:
YOu willtake lt'trczole *ntl soralbnib lirr 4 str*ight weeks (Days 1-?s). ll'you are prenrcn(lpausal, y,u havc estrogen produoliott liunt vour ovaries' Many premenopausal rvon:en lvill still be menstrultipg, glthough that nray not .tllvit\'s l"'c thc r:nsc iiir caeh woruun. Your <loctr:r will help ie clercidc il yuu ,rr* *iilt proment)Jrilrlr^al. "lo.ioirt this study vott rvill nectl to heuorle p()stnlen()pilusal t1 decrease ih* *rt.og*,., production liolll Yilur rvarles. l)ecrtasing \'$ur estrosen may help tr: lreat ,yogr. hreast cancer. 'l'his can b* done rvirlr surgcft to rcnrnvrl vour or,uries ur vyith a ine,nthiv injuctiorr inio fat or muscle ol.gurserelin or leuprolide. medicntiortx tltill stop vour ovnries fhrnr y:roducing estr{)gen. 'l"he injecriln lo clecrea*e estrogen pmrduction lrom y+trr ()vilrie s Lr{ln suu1 nt an1 time, incluelin[ rhe diy you start studv troiltnrent.  
  
  
  
  
Yor: r.vill ct:rttintr* tr receirre {lrese rrrr,j jl:atir-rrrs r.ruless:
. \'i:rU har,.. stvrlc, lrrr-iotr! llrtiJ.l*r (.\Lrcrii\if siii* cfircls.  
. \'ottr e onr:ct. lrct:iln).rJ \1,.ilI.st
. )"*tt r.i islr ltt 5trlp laJiil)!f 1:ri:rt ig this strrdl,.  
r:otrlitt tte lt.,iillnteil t.  
Allcr}'ott -st{il'( tlrr;ttlllt)nt r.t}u u"ill irlvc r}rc lir]lor.vin{ tcsts anri prt:ceclgrlls t1J}*rl  
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You will be asked questir:ns t* uheck how,vou are torerating the drugs. You will he askerl the.ext{,nt of'your physical acrivity ana tw you are generally lbeling. Your r.veight and heighr will hrr taken.  
Your bluod pre'ssure rvill be taken weekly during the first rl weeks ol trcalncnl. Ytlu will havt bl*rld tlrilrvn usirtg it small needle ,rr plastic tuhe, to check your hloo6 counts, your bl*od chcnristrl, 3n4 lr*w w*il y*ur kidne-vs and Iiver are working.  
Yuu will he givmr a rncdicatio,, r:liu,-r,and asketl to fill it out daily.  
Uig[1li] -\\'t'ck.s,
' Y'* lr,ili lraru lrl..ir ,.r'rrr..,,* trsirrg a sr*iril rictrirc,l li.ulr()t rr.lls r( l( s).  
plastic tuire tr-r check the level.s nl"circulating
Clinical trial: NCT00634634
Section: Withdrawal from Study
Subsections: Lnir.Vtdti,,Rl

'l'o the best of n:y abilirv, ittllrnttati gn cr3ltuinerl ilr lulrsweretl alrd tlr,"' paticrrl I h,i,* u.rpll.1i,",.,.1 ltrir"l rlisrusr.,*i, tlr* litll urlrrtents ol tlris corrsrrrt iirrrrr. .,\ll rlrrcstit;rrr oj. lirc r.usrlrr.uh irirs Lrct'tr gii,crrr I L:oll) r.lf tlit t:oltsclrt.  
the study including all of'the pstirint have bi:en iiccuratelt, Name ul'Investigatou
[)crsort Ohrai riing (.rr;15gn1.  
Signaturc:  
| -. Dule:   |
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Trxt eonlinuctt on nt'r{ plrgt  
  
!risrr,rr I l;;1'. ,1 1 r.: i, ;  
  
  
il l;tr{l- l in* 'l'hr:rapy in portrrrr.:rx;pausal
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