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A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
Palbociclib for HR positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (POLAR)
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string(552) "<\/p>\r\n
Biostatisticians' Report<\/strong>:<\/p>\r\n Current Accrual<\/strong><\/p>\r\n SAE<\/strong>:<\/p>\r\n Safety Reports<\/strong>: <\/p>\r\n IBCSG EC Statements<\/strong><\/p>\r\n <\/p>\r\n POLAR Trial Primary Analysis Database Lock Center Timeline- Final<\/a> (July 9, 2026)<\/p>\r\n SmPC Ibrance_11Dec2024<\/a><\/p>\r\n Protocol v3.0 training slides (please add this but leave the POLAR Training slides from April 2024)<\/a><\/p>\r\n Accrual Closure Letter<\/a> (February 4, 2025)<\/p>\r\n Frequently Asked Questions FAQs<\/a><\/p>\r\n Confirmation of Randomization Form<\/a> v2.0<\/p>\r\n POLAR Training Slides <\/a>April 2024<\/p>\r\n DFexplore Training<\/a> 19Sep19<\/p>\r\n Investigator Site Files Instruction<\/a>s v1.0 (March 23, 2022)<\/p>\r\n Investigator Site File Index<\/a> v2.1 (June 23, 2020) Drug Supply Manual<\/a> (v3.0 Jan 1, 2025) Patient Card<\/a> v1.0 (Nov 30, 2018) Investigation Report Label Template A4<\/a> (v2 July 15, 2019) Pre-screening log<\/a> (v1.0) CRFs:<\/p>\r\n Trial Communications:<\/p>\r\n <\/p>\r\n <\/p>\r\n Polar Data Request Schedule 2026<\/a> Center Information Sheet<\/a> V3.0 (Feb 2, 2016)<\/p>\r\n IBCSG COVID-19 Letter to sites<\/a> (March, 2020) Data Managers Manual<\/a> v1.0<\/p>\r\n IBCSG Dictionary of preferred terms for DWR and 2nd primaries<\/a> v5.1<\/p>\r\n {loadposition dfexplore}<\/p>\r\n {loadposition reg-rando-manual}<\/p>\r\n<\/div>","field53":"65"},"row3":{"field51":"Biological Material \/ Translational Research (Member)","field52":" {loadposition ffpe}<\/p>","field53":"65"},"row4":{"field51":"Biological Material \/ Translational Research","field52":" {loadposition biobank}<\/p>","field53":"1"},"row5":{"field51":"Results & Publications","field52":" Synopsis v1.1 (May 1, 2019)<\/p>\r\n Biostatisticians' Report: Current Accrual SAE: Safety Reports: IBCSG EC Statements Biostatisticians' Report: Current Accrual SAE: Safety Reports: IBCSG EC Statements POLAR Trial Primary Analysis Database Lock Center Timeline- Final (July 9, 2026) Protocol v3.0 training slides (please add this but leave the POLAR Training slides from April 2024) Accrual Closure Letter (February 4, 2025) Frequently Asked Questions FAQs Confirmation of Randomization Form v2.0 POLAR Training Slides April 2024 DFexplore Training 19Sep19 Investigator Site Files Instructions v1.0 (March 23, 2022) Investigator Site File Index v2.1 (June 23, 2020) Drug Supply Manual (v3.0 Jan 1, 2025) Patient Card v1.0 (Nov 30, 2018) Investigation Report Label Template A4 (v2 July 15, 2019) Pre-screening log (v1.0) CRFs: Trial Communications: Polar Data Request Schedule 2026 Center Information Sheet V3.0 (Feb 2, 2016) IBCSG COVID-19 Letter to sites (March, 2020) Data Managers Manual v1.0 IBCSG Dictionary of preferred terms for DWR and 2nd primaries v5.1 POLAR Trial Primary Analysis Database Lock Center Timeline- Final (July 9, 2026) Protocol v3.0 training slides (please add this but leave the POLAR Training slides from April 2024) Accrual Closure Letter (February 4, 2025) Frequently Asked Questions FAQs Confirmation of Randomization Form v2.0 POLAR Training Slides April 2024 DFexplore Training 19Sep19 Investigator Site Files Instructions v1.0 (March 23, 2022) Investigator Site File Index v2.1 (June 23, 2020) Drug Supply Manual (v3.0 Jan 1, 2025) Patient Card v1.0 (Nov 30, 2018) Investigation Report Label Template A4 (v2 July 15, 2019) Pre-screening log (v1.0) CRFs: Trial Communications: Polar Data Request Schedule 2026 Center Information Sheet V3.0 (Feb 2, 2016) IBCSG COVID-19 Letter to sites (March, 2020) Data Managers Manual v1.0 IBCSG Dictionary of preferred terms for DWR and 2nd primaries v5.1 {loadposition dfexplore} {loadposition reg-rando-manual} IBCSG Central Pathology Office Please ensure that the blocks and slides are carefully packed as otherwise they could easily get damaged during transport - irrespective of whether you send the tissue by post or courier. FFPE tumour samples should be packaged as follows: 1st a leak-proof primary container with absorbant padding material: e.g. plastic box padded with paper or similar material to prevent the blocks from moving. 2nd a leak-proof secondary packaging: e.g. ziplock plastic bag. 3rd Sturdy outer packaging: label with “EXEMPT HUMAN SPECIMEN IBCSG does not provide envelopes or boxes for the shipments. You may use standard, but appropriate, packing materials. FFPE Shipment Recommendations / Commercial invoice Commercial Invoice_IBCSG To avoid problems with the transfer of samples at customs it is essential that the material is correctly labelled, and a commercial invoice accompanies the package. To send FFPE tumour samples precisely write: “EXEMPT HUMAN SPECIMEN NON-CONTAGIOUS, NON-INFECTIOUS AND NOT IATA RESTRICTED”. {loadposition ffpe} {loadposition biobank} Synopsis v1.1 (May 1, 2019) Synopsis v1.1 (May 1, 2019) Protocol Release Date Trial Activation Date First Patient In Accrual Closure Date Global Trial Completion Date Protocol Release Date Trial Activation Date First Patient In Accrual Closure Date Global Trial Completion Date\r\n
\r\n
\r\n
\r\n
IBCSG IDMC Memorandum<\/strong>:<\/p>\r\n\r\n
\r\n
Trial 59-19 POLAR Specific Resources<\/h2>\r\n
Authorization Log<\/a> (Nov 30, 2018)<\/p>\r\n
Appendix 1 TDF<\/a> (v1.1 Jan 3, 2025)
Appendix 2 PCF<\/a> (v1.1 Jan 3, 2025)
Appendix 3 DAL <\/a>(v1.2 Jan 3, 2025)
Appendix 4 DL<\/a> (v1.1 Jan 3, 2025)
Appendix 5 DC<\/a> (v1.2 Jan 3, 2025)
Appendix 6 TL<\/a> (v1.1 Jan 3, 2025)<\/p>\r\n
Pathology Report Label Template A4<\/a> (v1 July 15, 2019)
Pathology Report Label Template Let<\/a> (v1 July 15, 2019)<\/p>\r\n
Investigation Report Label Template Let<\/a> (v1 July 15, 2019)<\/p>\r\n
Patient Sreening Log<\/a> (v1.0)<\/p>\r\n\r\n
\r\n
Newsletter<\/h2>\r\n
\r\n
General Resources<\/h2>\r\n
Authorization Log Manual V3.0<\/a> (March 2011)<\/p>\r\n
General Obvious Corrections Signature Page<\/a> v2.0 (Aug 28, 2015)<\/p>\r\nFFPE Tumor Tissue
Pathology Material Transfer Sheet<\/h2>\r\n\r\n
\r\nFFPE Material Shipment<\/h2>\r\n
Newsletter<\/h2>","field53":"65"},"row6":{"field51":"Former Protocol Documents","field52":"
Protocol<\/h2>\r\n
\r\n
\r\n
\r\nAppendices<\/h2>\r\n
\r\n
Protocol
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Appendices
IBCSG IDMC Memorandum:
IBCSG IDMC Memorandum:
Trial 59-19 POLAR Specific Resources
Authorization Log (Nov 30, 2018)
Appendix 1 TDF (v1.1 Jan 3, 2025)
Appendix 2 PCF (v1.1 Jan 3, 2025)
Appendix 3 DAL (v1.2 Jan 3, 2025)
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Trial 59-19 POLAR Specific Resources
Authorization Log (Nov 30, 2018)
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Newsletter
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Pathology Material Transfer Sheet
FFPE Material Shipment
Postal Address
European Institute of Oncology, EIO
Attn. S. Andrighetto/E. Benini
Division of Pathology
Via Ripamonti 435
20141 Milano
Italy
Email:
Fax: +39 02 94 37 92 94
Tel: +39 08 57 48 99 28
Packaging
Updated docs
IATA Certification_IBCSG
FFPE Shipment Recommendations_IBCSG
FFPE Shipment Recommendations / Commercial invoice
FFPE Tumor Tissue
Pathology Material Transfer Sheet
FFPE Material Shipment
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December 07, 2018
June 25, 2019
August 27, 2019
January 31, 2025
N/A
ibcsg59_polar@frontierscience.org
December 07, 2018
June 25, 2019
August 27, 2019
January 31, 2025
N/A
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
Contact
Phone: +41 31 511 94 00
E-mail: contact@etop.ibcsg.org