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KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY~c5(~ uu)f"d ~oueGiCi1 a.1J31t!&~ iffog

o:tu+m.~.~. ~d1s ;jO~((9~d(k)+"eo1) e?.UFd Mtli ~O~ ~ocp;U~)REGJONALCENTREFOR CANCERRESEARCH& TREATMENT

MEMBEROF (INTERNATIONALUNIONAGAINSTCANCER),~

Fax

Grams: KIMIO

phone : 26560rd (Director): 26560708 (14 Lines): 91--80-26560723

r)j\tE':CtH)2~2008" '."', .'." " ,,' ,

ToDr.D. lokanathaProject Room. ZindaI BlockKidwaiMemorial Institute of Oncology,Dr. M. H. Marigowda Road.Bangaiore-5OO029

mlf ~O.;;Mf.~o~~z.3ort~dJ- 560019WN6~J ~~Dr. M.H. Marigawda Road,Bangalore -~60 029.KARNATAJ<A. INDIA

Reference : Stuu--'yTitle: BIG1-06lEGF106903:".4 raniJomlze4 multJcenter opeII-label phase IIIstudy of neoadjuvant lapati~ trastuzumab and theircombination plus paditaJtel in women with HER2IEdi82 positive

. primary breast ~: Ethics Committee Approval for the conduct of the referenced study at

KidwaiMemoria!Institute of Oncology ,Dr.M. H. Marigcwda Road,Bangalore-560 029

Subject

Dear Dr.Lokanatha,

This is further to fetter of iW~ sub.- 16 . of doaJments of theyour- "-,,', ',n.," ag""cop;es

refe.enced study. At the meeting at the Committee on 3b.f.~. it was decided toapprove the conduct of the study under your direction at Kidwai Memor".alInstitute ofOncology. Dr- M. H- Mangowda Road,Bangalore-560 029. after rev=.ewof the followingdocuments:. Investigator's Brochure of lapatinib (GW512016) Docu.rnent No:

RM2000100481/06-dated 06 AprIl 2007.. Yourupdated CuntculumV'~8

The foHowingdocuments were also reviewedand have been approvedfor use in theirCUlTentform; " "

i. 'Study No: BIG1..Q6IEGF106903~"A randomized~ multicer.ter open-label '

phase III $fUdy of neoadjuvant lapatinib, trastuzt.ifllab ami theircombination phI$ paditaxe1 in women with HER2/EItJB2posifive -primarybreastcancer-ProtocolNo:G-UZOO7/OOO82IDO-dated19 Feb 2007

2. Investigator's Brochure of Lapatinib (GW572016) Document No:RM2000100481f06..dated 06 A.pril2007- '

3. Written Infonned Consent Form, English version 02.01 dated 20 July 2007(Core ICF)- 16 Copies ' '

", '''' .. L - -.. .. hJ!,t! v.l6 1istered under Kamataka Societies Registration Act 1960, Regn. No. S475n9-80 Donations to this Institute are exempt

from income Tax uls SOGof IT Act. 1961 and under ~. 35 (i) & (iOof IT Acl1961E-mail: J'OQt@kidwai.kar.nic.m

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",

G'ramspr.c.ne

Fax

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KIDWAI 1\1EfJlORIAl INSTITUTE OF ONCOLOGY~t1e§w 6WF"cf ;dol1.rc>('QiS~ 2!!~ weog

o:1>J.g).~.k ;;ifj~ ~Oi,(6ogdoats,foj.) et.,UFr;;$M('n ~dRia ;3o~MiiS)REGIONAL CENTRE FOR CANCER RESEARCH & TREATMENT

MEMBER OF (INTERNATIONALUNIONAGAINSTCANCER)

~ 11 c"i)Q.~w. 'd:;o~z ~: KIMIO donMd;) -560 029

: 26560722 (Director) ~N*"'!:J!,~d3.: 26560108 (14 Un~\ . Dr.M.H.MangowdaRoad,: 91-80-2656012 I BangaJore ~ 560029.

4. Written I~rmed Consent Form. Hindiversion 02_01 dat~~T~~ICF)

5- Back translation of the Hindi.translation of Written Informed Consent Form,Hindiv~on 02-01 dated 20 July 2007 (Core ICF)

6. Written Informed Consent Form, Tamilversion 02.01 dated 20 July 2007 (cOreICF)

7. Back transJation of the Tamil translation of Written informed Consent Form,Marathi version 02.01 dated 20 July 2007 (Core ICF)

8. Written 'nfonned Consent Form. MalayaJam version 02.01 dated 20 July 2007(Core 1Cf)

9. Back translation of the Malavalam translation of Written Informed Consent,Form. Marathiversion 02.01 dated 20 July 2007 (Cme ICF)

10. Written Informed Consent Form, TeJugu version 02.01 dated 20 July 2007(Core ICf)

11. Back translatiOn of the Telugu translation of Written Infonned Consent Form,Marathi version 02.01 dated 20 Juty 2007 (Cere ICF)

12. Written Informed Consent Form, Kannada version 02.01 dated 20 July 2007(Core ICF)-16 Copies

13- Back translation of the Kannada translation afWritten Informed Consent Form,Marathi version 02.01 dated 20 July 2007 (core ICF)-16 Copies

14. Written Infonned Consent Form, English vemion 01.01 dated 20 July 2007(Pharmacogenetic Research on Blood 1Cf) -16 Copies

15- Written Informed Consent Form, Hindi version 01.01 dated 20 July 2007(Pharmacogenetic Research on Blood ICF)

16~ Back translation Of the Hindi translation of Written Informed Consent Fonn.Hindiversion 01.01 dated 20 July 2007 (Pharmacogenetic; Research on BloodICF)

17. Written Infonned Consent Fonn, Tamil version 01.01 dated 20 July 2007(Pharmacogenetic Research on Blood iCf)

18- Back translation of 1he Tamil translation of Written Infooned Consent Form.Marathi version 01.01 dated 20 July 2007 (Pharmacogenetic Research onBI~I~ .

19. Written Informed Consent Form, Malayalam version 01.01 dated 20 July 2007(Poormaccgenetic.Research on Blood ICF) <

< . . .F~" vJ-(j :2gistered under Kamataka Societies Registration Act 1960. Regn. No. S475n9-80 Donations to thIS Institute are exempt

from income Tax <ulsBOGof tT Act, 1961 and under Sec. 35 (i) & (ii) of IT Act 1961E-mail: root@kidWai.kar.nlo.in

. ,..i.1"T:'\nfi\'\. - ~~ ~ - Q, ~ -'U \..~CI . u.AJ ;:."iiJv Q n U in ;..,ON

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KID\./AI ~1EtJlORIAL INSTITUTE OF ONCOLOGY~d~~~ f!U)nj 7JO~fQt« c.iJ~ ~~ «~og

C\1).).~,~.~. ~tS~ J!°li(a~dua,,~cro ~Wf'cj M~n ~d~ :;;O~~~)REGiONAL CENTRE FOR CANCER RESEARCH & TREATMENT

MEMBER OF (INTERNATIONAL UNIONAGAINST CANCER)

as;.. WQ.ww. ~~~ ~Grams: KIMIO don~-s6oo29

phone: 26560722 (Director) ~i"~, ~.. 265 60708 (14 U ~...\ Dr. M.H. Mangowda Road,

: 1 - noo-='I - Bangalore - 560 029.. :m.-80£~6~~a+jon of the Malayalam translation of 'V\"rittelfJ'l~d~rit

Form, Marathi version 01.01 dated 20 July 2007 (Pharmacogenetic Researchon Blood ICF)

21. Written Informed Consent Form, Telugu version 01.01 dated 20 July 2007(Pharmacogenetic Research on Btood ICF)

22. Back translation of the Telugu translation of Written Informed Consent Form,Marathi version 01.01 dated 20 July 2007 (Pha.rmacogenetic Research onBlood ICF)

23- Written fnfOllned Consent Form. KaMada version 01.01 dated 20 July 2007(Pharmacogenetic Research on B!ood ICF)-16 Copies

24~ Back translation of the Kannada translation of Written Informed Consent Form,Marathi version 01.01 dated 20 July 2007 (phannacogenetic Research onBlood ICF) -16 Copies

25. Written Informed Consent Form, English version 02-01 dated 17 Sept"'2007(Consent Diagnostic Biopsy 1eF) -16 Copies

26- Written Informed Consent Fo!u!, Hindi version 02.01 dated 17 Sept 2007 .(Consent Diagnostic Biopsy ICF)

27. Back tranSlation of the Hindi translation of Wlilten Informed Consent Form.Hindiversion 02.01 dated 17 Sept 2007 (Consent Diagnostic Biopsy ICF)

28. Written Informed Consent Form. Tamil version 02.01 dated 17 Sept 2007(Consent Diagnostic Biopsy ICF)

29. Back translation of the Tarml translation of Written Infonned Consent Form,Marathi version 02.01 dated 17 Sept 2007 (Consent Diagnostic Biopsy ICF)

30. Written Informed Consent Fonn, Malayatam version 02.01 dated 17 Sept 2007(Consent Diagnostic Biopsy ICF)

31. Back translation of the Malayalam translation of Written Informed ConsentFonn, Marathi version 02-01 dated. 17 Sept 2007 (Consent Diagnostic S,opsyICF)

32. Written informed Consent Form, TeJugy ~rsion'02.01 dated 17 Sept 2007(ConsentDiagnosticBiopsyICF) .

33- . Back translation of the Telugu translation of Written Informed Consent Form,Marathi Yel'$ion02.01 dated 17 Sept 2007 (Consent DiagnosticBiopsy ICF)

34. Written Informed Consent Form, Kannada version 02.01 dated 17 Sept 2007(Consent Diagnostic Biopsy ICF)

"

Fax

~ IJIJJ

I

..

FtL1;~ <1fiJ 3leglstared under Kamataka. Soclef.es Registra1ion Act 1960, Regn. No. S475n9-BO Donations to thIs Institute are exempt

from Income Tax uls BOG of IT Act, 1001 and under Sec. 35 (i) & (ij) of IT Act. 1961E-mail ;root@kidwai.kar.nic.in

'- ~ I).\}4

Grams: KIMIQ

phone: 26580722 (Director): 26560708 (14 Unes)

Fax: : 91-80-26560723

ft - " ""' J R\"'" .JJ6'CJa ro,) ~utJ nO'fl NON~ $I ti)

KID\YAI 'JlEft,10RIAL INSTITUTE OF ONcOLOGY

~de§w ~tJ.)f"d ;jo~eGS~ ;;t)~ ~~~ tJtOsoiU. g).~.~. ;J~ ;jo~ (~o;!dt)rj;"eg.1) eWF"d d.'6frl ~dfS ;;;oij'Ytd~)

REGiONAL CENTRE FOR CANCER R~SEARCH & TREATMENTMEMBER OF (INTERNATIONAL UNION AGAINST CANGER)

~II we.~. ~af'ila~t3orlu~ - 560029i&1:lM3!, ~d;:j

Dr.M.H.MarigowdaRoad,Bangalore - 560 029.KARNATAJ<A. INDIA

~-

35. Back transtation of the Kannada tTanslatio.,of VVrittenInformed Consent Fonn,Marathi version 02_01dated 17 Sept 2007 (Conse.it Diagnostic Biopsy ICF)

36. Emergency' Unblir.ding Cards in F=nglish,Hindi, Kannada, Tamil, Telugu &Maiayalam- .

37. CRF annotated Design for the Tri. BIG1-D6JEGF106903Dated- 20 June2007-

38. PharmacogeneticsPatient Brochureiii E."".glis."l.Hindi. IC.anrL.Slda.Tamil, Telugu&Malayalam-

39.

40.

41.42.43.

Bajaj lfiSUiai'iCefor the refere.f!C8dstud:ie$,

Cfin~1 TriafCompensation Guidelines by ASPi.

Indemnity letter,Letter of Submission to DCGi dated 31 Cd 2007

DCGffl,.nprovaJLetter dated 26 Nov 2007

The foflowingmembers participated In the meeting:

Sr. no. Name DesIgnation! Occupation Gender

CHAIRMAN:

~:;thri MPCbinnappa.Retired Justice .

. High Court of KarntakaB;m.,~ore

Legal EApert Male

tegisferedunderKamatakaSocietiesReg~~~~.~ 19130.Regn.No-8475/79-80Donationsto~in~ 1re e".-emptfrom Income Tax uis aOG of IT Act, 1961 s'!'.d LlT1derSee, 35 (I) & (ii) of IT Act 1961

E-mail: root@k".d..~..<ilLkar.njc.ln

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I-otJe)~Q).) ~do noR\ ~o;S

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KIDWAI I\,.EMORIAL INSTITUTE OF ONCOLOGY~dtlj'd ~t})f"d ~OU~Q~ ~ $~ ~eo9

Q1)).g).~.R.:7.Sd~;;i°t(eogoG8"to.iJ UWf"C dArn ~d~ ;;!Q~Ui3)REGIONALCENTREFOR CANCERRESEARCH& TREATMENT

MEMBER OF (INTERNATiONALUNIONAGAINSTCANCER)

Grams: KIMIO

phone : 26560722 (Director). .kfMWP~ (14Unas)

Fax 11'~~O723

ProfB.N. GangadharMedical8u~&. Profesoor ofPgychiatryNJMHA}.'"SBangUJre

Psycbiatri$t

Qt)IIwe..~. ~0Uf9~ ~z5l:!rI~c., -560 O%!i

\fmF"6o3f. Q;dar

Dr. M.H. Marigowda Road,Bangalore - 560 029.tC.ARNMAKA.INDIA

Male

Dr. vlS2llitbaKamathProfessor &.Head, Dept of MedicineBangalore A-1e<JjtJSlCoUegeBaogaion;

Prof &:HOD, MecJjclne Fema~ .

Dr_IayandUProfessor & HeDd, Dept ofPbarmaooJogyBaogaiorc Medif=aICollegeBangalore

Prof & HeadPbarma£ology Female

Dr. eM. j~iFonner Principai,BMCBangatore

Pathologist MaJe

Dr. :RameshS Bilimag"D~ (J.\iediciU)Bangalore Instituie of OncologyBangatore

Radiation Onoologi<it MWe

Dr. RadbeshyamMedical Om:ologistBangaJore

Medica) Onc(tlog;st Maie

Sri G.S- Gnndu .RaoBangalore

Social Activitist Mait:

MEMBER-SECRETARY:

Dr. Vij!!yaI..axmiI>esImiaoI;Director (lie). KMlO8anga1ote

Surgicai Qnetiktgi!;; Famde

LIASION OFFICERS:

Dr. S. Krish1;Jarnurthy Surgical Oncologist Male

. ~.." 1'«1$""1J.ItJ 5~istered under Karnataka Societies Registration Act 1960. Regn. No. 8415179-80 Donations to thIS In$tit~* are 6A<Jmpt

from income Tax uls 60G of IT Ad,. 1961 and under Sec. 35 (i) &.{ii)of IT Act. 1961. E-mail: root@kidwaLkar.nicoin

Igj UUt5

oC]C;Q1)iJi)d~ nolP ;::o~os e, CPKiD\,VAIrJlE"'ORIAL INSTITUTE OF ONCOLOGY

~d(A1:i eWF"d ;jo~J~~Q~ ~ t36~ 1f~ot;

(1).}.m.].:.!:.:ud-\ :ijo;3t;)(~o~d~~eo.D eWf"d tU~rl ~d~ ~o~~~)

REGIONALCE!\.ITREFOR CANCERRESEARCH &TREATMEi'liMEMBEROF (INTERNATIONALUNIONAGAINSTCANCER)

~ \I .wo.ot81. ;i;!Oti'f'ilal~C~tb- 560 OZ9~~~UtI. ~dSOr. M.H. MariQowda Road,Bangalore -560 029KARNATAKA. INOIA.

Grams: KIMO"Phone: 26560722 (Director)

: 26094000Fax: 91 -80 - 26560723

Mcmber-Secre1aly,SRB, KMIO

Mr. S. Siddalin~swamyPublic Relations Officer

Social Service Maie

Please note that the Co:!nmitteeis constituted as per ICH-GCPand ICIIIRguidelin-.

Kindlynotify the submission and approvai ietters from tt.e DCGI to the Committee,before study initiation.The Committee also expects to be informed about the ~~1'ii~progress of the study, any SAE occuning in the course of the study, any changes in theprotocoland patient information / informed consent and asks to be provideda copy ofthe final report

Dr. Vijaya Laxmi Des.1,manehas not p:k'1icipatedat the time of voting of this trial

W3(DR VlJAYA LAXMJ DESHMANE)MEMBER-SECRET.6.,RYMEDICAL ETHICS COMMITTEE

Registered onder Kaniataka. SocistiQ$ Registration Act 1960. Regn. No..5475/79-80 ponan€H;'l{~nstit'..'ts.are exemptff6ffl it1GOI"TI6Tax uls BOGof ITAr;t, 1961 and under Sec.. 35 (I) & (Ii)of iT Aot. 1961

E-mail: roQt@lddWaLkar.nic.in .