. -

TATA MEMORIAL HOSPITAL

Date: lOth Mm-ch 2008.

DR. EARNEST BORGES RO,4PAREL,MUMBAI~400 012Phone: 24177000Fax: 91-22 2414 6937E-mail: medimail@fmc.ernet.i

HOSPITAL ETHICS COMMITTEE

To,

Dr Reena NairPrincipal Investigator, Protocol EGF 106708Additional Professor,Department Of~1edical Oncology,Tata Memorial Hospita4Dr Ernest Borges road,Parel, Mumbai-4000 12.

Reference: ProtocQI Title: AL1TO (Adjuvant Lapatinib and/or Trastuzumab

Treatment Optimisation) study. A randomised, multi-centre, open-label,phase III study of adjuvant lapatinib, trastuzumab, their sequence andtheir combination in patients with HER2/ErbB2 positive primary breastcancer.Final version;05Feb 2007ProtocOlNumber: EGFI06708

Subject : Approval of the referenced study

Dear Dr Reena Nair,

It was decided ro approve the conduct of the above referenced study under your directionat the Depa.~ent Of Medical Oncology, Tata Memorial Hospital, after review of thefoUowingdocuments:

Meeting held on 28 September 2007:

. Investigator's Brochure of Lapatinib, version 07, dated 06-April-2007

.. Bajaj Allia..-raInsurance policy dated 07-Aug-2006.

. Clinical trial compensation guidelines ,in English. Issued Ian 1991, Reprinted inMar 1994

In addition to these documents, the following documents were also reviewed and havebeen approved for use in their current form:

1. Protocol Title: ALITO (Atfjuvant Lapatinib and/or Trastuzumah TreatmentOptimisation) study. A randomised, multi-centre, open-label, phase III study of,.

Project No. 436 Page 1 of 4

19 Ma~ 200B 18:23 HP LASER JET FAX p.3

adjU'r/Ch"'ltlapatirdb. trasrJZUmab. their sequence and their combination in patientswith HER2/ErbBl positive primary breast cancer. GM2006100694101(Finaldated 05-Feb-2007). ProtocolNumber:EGFI06708

2. Case Report Forms

STUDY ICFs

3- Patient Infonnation sheet for participation in the ALTTO clinical study, versionvi-vI Dated: 29 January 2007

4. Hindi translation of Patient Information sheet for participation in the ALTTOclinical study, version 01.01 Dated: 29 January 2007

5. Backtrans1ationinto English of the Hindi translation of Patient Infonnation sheetfor participation in the ALITO clinical study, version 01.01 Dated: 29 January2007

6. Marathi translation of Patient Information sheet for participation in the At TTOclinical study, version 01.01 Dated: 29 January 2007

7. BacktnLnslationinto English of the Marathi translation of Patient Informationsheet for participation in the ALTTO clinical study, version 01.01 Dated: 29'~"'H"_T ')(\(\7

"Q.U.~J' ~"VU',

PGx ICFs

8. Patient Information sheet for participation in the ALTTO clinical study, OptionalPhJirmacogeneticResearch~ version 01.01 Dated: 29 January 2007

9. Hindi translation of Patient Information sheet for participation in the ALTIOclinical study. Optional Pharmacogenetic Reseal"};...version 01.01 Dated: 29JanUfu] 2007

1Q.Ba.cktranslation into English of the Hindi translation of Patient InfoImaUon sheetfor participation in the AL'ITO clinical study, Optional PharmaCOgfuleticResearch, version Ol.Oi Dafed: 29 Janua.ry 2007

11. Marathi translation of Patient Information sheet fOrparticipation in the ALTTOclinical study. Optional Pharmacogenetic Research, version 01.01 Dated: 29Jeu'wllY2007

Project 1>10.436 Page 2 of 4

19 Ma~ 2008 18:23 HP LA£ER.JET FAX p.4

12. ~k.1:ron~lation into English of the Marathi translation of Patient informationsheet for participation in the AI...ITO c1iPlcal study, Optional. PbarmacogeneticResearc~ version 01.01 Dated: 29 January 2007

13. Principal Investigator's Undertaking to the DCOI

14. Principal Investigator's updated Curriculum Vitae

The following documents submitted by you to the Hospital Ethics Committee fornotification were reviewed on 10January 2008;

1. D.C.OJ. A.pprovalletter and Import license; dated 05-July-2007

2. DUFT license; dated 14-Se}>"2007

3. Baj~ Allianz Certificate of~ effective 07-Aug-2007

In addition to the above mentioned documents, tIre following documents were alsoreviewed and approved:

1. Emergency cards in English, Marnthi and I:lindi

2. Patient Information sheet for participation in the ALTIO clinical study, version0-2.03Dated: 24 October 2007

3. Hindi translation of Patient Information sheet for participation in the ALTIOclinical study, version 02.03 Dated: 24 Oc"wber2007

4, Backtransiation into English of the Hindi translation of Patient Information sheetfOrparticipation in the ALTTO clinical study, version 02.03 Dated: 24 October2007

5. ML~tU translation of Patient Information sheet for participation in the ALTIOclinicai study, version 02.03 LJa.-ted:24 CJCt..oDe-r2007

, r- .."' n---" _1';

rrqjecr 1'\1[}. 'f:Jf} rai!,'?;;} f.lJ.<f

J.::J I~a~ l:"UUI::I ID:£'::i HP LRSERJET FAXp.S

Backtranshttion into English of the Mamthi translation of Patient Informationsheet for participation in the ALTIO clinical study,. version 02.03 Dated: 24October 2007

6.

7. Clinical trial compensation guidelines in Marath.i and Hindi, Issued Jan 1991,Reprinted in Mar 1994.

Designation! Occu -

ChaiIperson. Consultant, Breach

I Candy Hospital ~Dr K..A.Dinshaw I Director~TMC Female

IDrR.c. Mistry I Secretary,D&SMSC& Professor,! Malet IDept ofSurgcry . I~IDr RF -Chinoy t HewLD t ofPathol .TMH Female

IDr. M Muckaden OTC Palliative care & Professor, Female

~ . . I Dept of RadiotJrernpyIDr Pankai Chaturvedi i Asso. Prof. Dept of Surgery

'I ~,."._.]1..- T~_L: i U~A f"\ +.-.4'Ta.Q..i VI: l"'l~ JV;'Jil1.1 1 .. "~"""'-. L.""";.o" "'... -'J~'" ,.,...

i r...h-s.Var;&r..ai,~.Ip~ I FOlliider l'..lcmbeJ:-V~~-e-

The following members participated and voted in the meeting.

Srno1

'onNameDr R.P.Soonawala

6-I

g

GenderMale

~! Femalei ~, .. ...1 ;,~!ni::<!~

....

. .,-, ,',","." ~~~'" "'-'~'-'-~-' ..~. - -_. ---'---'--"

=J.

'~'---~.' -~~"~ --- - .~.""--'._"~'-,~ .-. .. ,. .-~.- ,. - ~~_.- ~ --- ~~.._-

:~:~~::;]~~~h~:~~~'?:t=;~~'=~:;5~~::0~J~E:~~~~-'-'-"-'-'-''''H''''''''V~' ~'J~~ ~'J~'---' -- -~--- -- - - r-' , r -

- "I f!4ii¥.l.'1g YOU-,

y oun~ Sincerely,tA~.! ..~

ft~hQ Tn..hiDi'M "'.........-S~. BEC-IITata MemorlR.lHC'.spimlDr Ernest Borges road,Parel~ Murnbai-400012

F-rojea No. 436 Page 4 of 4