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Date: 21 Dec 2007

ToDr. Minish Jain,Consultant Oncologist,Ruby Hall Clinic-Cancer Centre40, Sassoon road, Pune-411001

Reference

Subject

Protocol BIG1-06/EGF106903:"A randomised, multicenter open-label phase 11/study of neoadjuvant lapatinib, trastuzumab andtheir combination plus pac/itaxe/ in women with HER2/ErbB2positive primary breast cancer"

Dear Dr. Jain,

: Approval of the above referenced study

This is further to your letter of 30 Oct 2007, submitting 09 copies of documents of thereferenced study. At the meeting of the Committee on 21 Nov 2007, it was decided toapprove the conduct of the study under your direction at Ruby Hall Clinic, 40,Sassoon Road, Pune - 411001, after review of the following documents:

ii Investigator's Brochure of LapatinibRM2000/00481/06-dated 06 April 2007.

ii Your updated Curriculum Vitae

(GW572016) Document No:

The following documents were also reviewed and have been approved for use in theircurrent form:

1. Study No: BIG1-06/EGF106903: "A randomised, multicenter open-labelphase III study of Neoadjuvant Lapatinib, Trastuzumab and theircombination plus Paclitaxel in women with HER2IErbB2 positive primarybreast cancer" Protocol No: GM2007/00082100-dated 19 Feb 2007

Written Informed Consent Form, English version 02.01 dated 20 July 2007(Core ICF)

Written Informed Consent Form, Hindi version 02.01 dated 20 July 2007 (CoreICF)Back translation of the Hindi translation of Written Informed Consent Form,Hindi version 02.01 dated 20 July 2007 (Core ICF)

Written Informed Consent Form, Marathi version 0201 dated 20 July 2007(Core ICF)

2.

3.

4.

5.

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6. Back translation of the Marathi translation of Written Informed Consent Form,Marathi version 02.0~ dated 20 July 2007 (Core ICF)

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

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

Back translation of the Hindi translation of Written Informed Consent Form,Hindi version 01.01 dated 20 July 2007 (Pharmacogenetic Research on BloodrCF)

Written Informed Consent Form, Marathi version 01.01 dated 20 July 2007(Pharmacogenetic Research on Blood ICF)Back translation of the Marathi translation of Written Informed Consent Form,Marathi version 01,01 dated 20 July 2007 (Pharmacogenetic Research onBlood ICF)

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

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

Back translation of the Hindi translation of Written Informed Consent Form,Hindi version 02.01 dated 17 Sept 2007 (Consent Diagnostic Biopsy ICF)

Written Informed Consent Form, Marathi version 02.01 dated 17 Sept 2007(Consent Diagnostic Biopsy ICF)Back translation of the Marathi translation of Written Informed Consent Form,Marathi version 02.01 dated 17 Sept 2007 (Consent Diagnostic BIopsy ICF)

Emergency Unblinding Cards in English, Hindi & Marathi.

CRF annotated Design for the Trial- BIG1-06/EGF106903 Dated- 20 June2007.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

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19. Pharmacogenetics Patient Brochure in English, Hindi & Marathi.

The following members participated in the meeting:

1. Mr. A.J. Castellino2. Dr. D.N. Bhalerao3. Dr. R.S. Wadia4. Dr. R.B. Gulati5. Dr. C.P. Bajpayee6. Dr. S.G. Deshpande7. Dr. Prachee Sathe8. Mrs. M. Kulkarni9. Ms. Goal Patel

ChairpersonVice chairmanNeurophysicianCardiologistNeurosurgeonSurgeonIntensivistAdvocateSocial Worker

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POONAMEDICALRESEARCHFOUNDATION40, SASSOQNROAD, PuNE 411001. ref 02Q 26 w~~

NOTIFIED ASSOCLATION UlS 35 '1) (ii) or !-iF~ 26'23973

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Please note that the Committee is constituted as per ICH-GCP,Schedule Y andICMRguidelines.

Kindly notify the submission and approval letters from the DCGI to the Committee,before study initiation. The Committee also expects to be informed about the biannualprogress of the study, any SAE occurring in the course of the study. any changes in theprotocol and patient information I informed consent and asks to be provided a copy ofthe final report.

Kind regards,

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DR. D.N. BHALERAO~ VICE CHAIRMAN

ETHICS COMMITTEE

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ETH TEEPOONA MEDIC/\t . rOUNDAtlQN

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GRANT MEDICALFOUNDATION40 Sassoon Road, Pune 411001. Tel. : 020 -26123391 Fax' fj4:1.i ;:6123973