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IBCSG 45-13 PANACEA
A phase Ib/II trial evaluating the efficacy of MK-3475 and trastuzumab in patients with trastuzumab-resistant, HER2-positive metastatic breast cancers.
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string(552) "Biological Material / Translational Research
Protocol<\/h2>\r\n\r\n- Protocol v 2.1, Amendment 1<\/a> (January 11, 2016)<\/li>\r\n
- PI Protocol Signature Page<\/a> v2.1 (January 11, 2016)<\/li>\r\n
- Amendment Changes document<\/a> (January 22, 2016)<\/li>\r\n
- Cover Letter Amendment 1<\/a>, ANZ_BCTG (version January 11, 2016)<\/li>\r\n
- Cover Letter Amendment 1<\/a>, AUS (version January 11, 2016)<\/li>\r\n
- Cover Letter Amendment 1,<\/a> BEL (version January 11, 2016)<\/li>\r\n
- Cover Letter Amendment 1,<\/a> FRA (version January 11, 2016)<\/li>\r\n
- Cover Letter Amendment 1<\/a>, ITA (version January 11, 2016)<\/li>\r\n
- PIS\/IC<\/a> v2, January 11, 2016<\/li>\r\n
- Announce Opening<\/a> (December 10, 2014)<\/li>\r\n<\/ul>","field53":"51"},"row1":{"field51":"Current Status","field52":"
- Biostatisticians Report:<\/strong><\/p>\r\n\r\n- Biosticians' Report 2018<\/a><\/li>\r\n
- Biostatisticians' Report 2017<\/a><\/li>\r\n
- Biostatisticians' Report 2016<\/a><\/li>\r\n
- Biostatisticians' Report 2015<\/a><\/li>\r\n<\/ul>\r\n
- Current Accrual<\/strong><\/p>\r\n\r\n- Final Accrual<\/a><\/li>\r\n<\/ul>\r\n
- IBCSG DSMC Memorandum<\/strong>:<\/p>\r\n\r\n- November 13, 2017<\/a><\/li>\r\n
- May 18, 2017<\/a><\/li>\r\n
- November 7, 2016<\/a><\/li>\r\n
- June 1, 2016<\/a><\/li>\r\n
- <\/a>October 15, 2015<\/a><\/li>\r\n
- May 21, 2015<\/a><\/li>\r\n
- October 30, 2014<\/a><\/li>\r\n
- April 24, 2014<\/a><\/li>\r\n<\/ul>\r\n
- IBCSG EC Statements<\/strong>:<\/p>\r\n\r\n- March 2018<\/a><\/li>\r\n
- March 2017<\/a><\/li>\r\n
- March 2016<\/a><\/li>\r\n
- January 2016<\/a><\/li>\r\n
- March 2015<\/a><\/li>\r\n
- April 2014<\/a><\/li>\r\n<\/ul>\r\n
- SAE<\/strong>:<\/p>\r\n\r\n- Cumulative Report<\/a><\/li>\r\n<\/ul>\r\n
- Safety Reports<\/strong>:<\/p>\r\n\r\n- September 2016 - August 2017<\/a><\/li>\r\n
- September 2015 - August 2016<\/a><\/li>\r\n
- September 2014 - August 2015<\/a> <\/li>\r\n<\/ul>","field53":"51"},"row2":{"field51":"Data Management Resources","field52":"
Trial 45-13 PANACEA Specific Resources<\/h2>\r\n\r\n- Trial Closure Letter<\/a> (May 15, 2018)<\/li>\r\n
- Declaration End Trial Form<\/a><\/li>\r\n
- \r\n
Enrollment Closure Letter<\/a> (June 20, 2017)<\/p>\r\n<\/li>\r\n- \r\n
Screening and Enrollment Closure Letter PD-L1 Negative<\/a><\/p>\r\n<\/li>\r\n- \r\n
DBL Letter<\/a> (May 23, 2017)<\/p>\r\n<\/li>\r\n- \r\n
PI Consent Letter<\/a><\/p>\r\n<\/li>\r\n- \r\n
Enrollment Pause Letter Phase II First Stage<\/a><\/p>\r\n<\/li>\r\n- Pathology Report Label Template Letter<\/a> (Avery 5962)<\/li>\r\n
- Pathology Report Label Template A4<\/a> (Avery 3653)<\/li>\r\n
- Investigation Report Label Template Letter<\/a> (Avery 5962)<\/li>\r\n
- Investigation Report Label Template A4<\/a> (Avery 3653)<\/li>\r\n
- Pathology Report Label Instructions<\/a><\/li>\r\n
- Investigation Report Label Instructions<\/a><\/li>\r\n<\/ul>\r\n
Investigator's Brochure<\/p>\r\n
\r\n- Edition 13<\/a><\/li>\r\n
- Edition 12<\/a><\/li>\r\n
- Edition 11<\/a><\/li>\r\n
- Edition 10<\/a><\/li>\r\n
- Edition 9<\/a><\/li>\r\n
- Edition 8<\/a><\/li>\r\n<\/ul>\r\n
\r\n- Blood Samples Logistics Manual<\/a> v1.1 (Feb. 10, 2016)<\/li>\r\n
- Blood Samples Logistics Manual<\/a> v1.0 (Nov 14, 2014)<\/li>\r\n
- Excel Chart for Blood Draws<\/a><\/li>\r\n
- Blood Crybox Map<\/a> Appendix 2<\/li>\r\n
- Blood Specimen Transfer Form<\/a> Appendix 3<\/li>\r\n
- Blood Temperature Deviation Report<\/a> Appendix 4<\/li>\r\n
- PPD Resupply Order Form<\/a> Appendix 5<\/li>\r\n<\/ul>\r\n
\r\n- Enrollment Control<\/a> v1.0 (March 22, 2016)<\/li>\r\n
- Phase II Open for Enrollment Letter<\/a> (August 27, 2015)<\/li>\r\n
- Enrollment Pause Letter<\/a> (July 23, 2015)<\/li>\r\n
- Enrollment Resumption Letter<\/a> (July 7, 2015)<\/li>\r\n
- Enrollment Pause Letter<\/a> (June 3, 2015)<\/li>\r\n
- Center Enrollment Slotting Procedures<\/a> (February 9, 2016)<\/li>\r\n
- Data Managers Manual<\/a> (March 5, 2015)<\/li>\r\n
- Data Managers Manual<\/a> Amendment 1v1.0 (February 9, 2016)<\/li>\r\n
- Pathology Procedures Manual<\/a> v1.1 (Feb. 10, 2016)<\/li>\r\n
- Pathology Procedures Manual<\/a> v1.0 (Dec 11, 2014)<\/li>\r\n
- Tissue Submission Form<\/a> v1.1 (Feb 10, 2016)<\/li>\r\n
- Tissue Submission Form<\/a> v1.0 (Nov 11, 2014)<\/li>\r\n
- Commercial Invoice<\/a><\/li>\r\n
- IATA Certification<\/a><\/li>\r\n
- Payment Info Form Tumor Blocks<\/a><\/li>\r\n
- Investigator Site File Index<\/a> v1.2 (Jan 22, 2015)<\/li>\r\n
- Frequently Asked Questions<\/a> FAQ v3.0 (June 10, 2015)<\/li>\r\n<\/ul>\r\n
\r\n- Cover Letter Austria<\/a><\/li>\r\n
- Cover Letter Belgium<\/a><\/li>\r\n
- Cover Letter France<\/a><\/li>\r\n
- Cover Letter Italy<\/a><\/li>\r\n
- Cover Letter ANZ BCTG<\/a><\/li>\r\n<\/ul>\r\n
File Note Template<\/a> v1.0 (Aug 12, 2014)<\/p>\r\nAmendment 1 CRFs:<\/p>\r\n
\r\n- A1<\/a> A4<\/li>\r\n
- A2<\/a> A4 v2.0<\/li>\r\n
- PREG<\/a> A4<\/li>\r\n
- SAE\/ECI-A A4<\/a><\/li>\r\n
- SAE\/ECI-B<\/a> A4<\/li>\r\n<\/ul>\r\n
\r\n- A1<\/a> Let<\/li>\r\n
- A2<\/a> Let v2.0<\/li>\r\n
- PREG<\/a> Let<\/li>\r\n
- SAE\/ECI-A Let<\/a><\/li>\r\n
- SAE\/ECI-B Let<\/a><\/li>\r\n<\/ul>\r\n
Drug Accountability Log<\/a> v1.0 (Aug 8, 2014)
Drug Destruction Certificate<\/a> v1.0 (Aug 8, 2014)
Temperature Log<\/a> v1.0 (Aug 8, 2014)<\/p>\r\n <\/p>\r\n
\r\n- Drug Supply Manual v1.1<\/a> (Sept 19, 2014)<\/li>\r\n
- Drug Supply Manual v1.1 App1<\/a> (Sept 19, 2014)<\/li>\r\n
- Drug Supply Manual v1.1 App2<\/a> (Sept 19, 2014)<\/li>\r\n
- Drug Supply Manual v1.1 App3<\/a> (Sept 19, 2014)<\/li>\r\n
- Drug Supply Manual v2.0 App 4<\/a> (Dec 10, 2014)<\/li>\r\n
- Drug Supply Manual v2.0 App4<\/a> (France) (Dec 10, 2014)<\/li>\r\n<\/ul>\r\n
- Biostatisticians Report:<\/strong><\/p>\r\n - Current Accrual<\/strong><\/p>\r\n - IBCSG DSMC Memorandum<\/strong>:<\/p>\r\n - IBCSG EC Statements<\/strong>:<\/p>\r\n - SAE<\/strong>:<\/p>\r\n - Safety Reports<\/strong>:<\/p>\r\n Enrollment Closure Letter<\/a> (June 20, 2017)<\/p>\r\n<\/li>\r\n Screening and Enrollment Closure Letter PD-L1 Negative<\/a><\/p>\r\n<\/li>\r\n DBL Letter<\/a> (May 23, 2017)<\/p>\r\n<\/li>\r\n PI Consent Letter<\/a><\/p>\r\n<\/li>\r\n Enrollment Pause Letter Phase II First Stage<\/a><\/p>\r\n<\/li>\r\n Investigator's Brochure<\/p>\r\n File Note Template<\/a> v1.0 (Aug 12, 2014)<\/p>\r\n Amendment 1 CRFs:<\/p>\r\n <\/p>\r\n\r\n
\r\n
\r\n
\r\n
\r\n
\r\n
Trial 45-13 PANACEA Specific Resources<\/h2>\r\n
\r\n
\r\n
\r\n
\r\n
\r\n
\r\n
\r\n
Drug Accountability Log<\/a> v1.0 (Aug 8, 2014)
Drug Destruction Certificate<\/a> v1.0 (Aug 8, 2014)
Temperature Log<\/a> v1.0 (Aug 8, 2014)<\/p>\r\n\r\n