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Phase II open-label, multicenter, randomized trial of neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade versus paclitaxel in combination with HER2 blockade for elderly patients with hormone receptor positive/HER2 positive early breast cancer.
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string(552) "Amendment PIS\/IC:<\/p>\r\n
English<\/a> v2.0 incl.GDPR (18 Feb 2020) <\/p>\r\n PISIC Addendum:<\/p>\r\n English<\/a> v2.0 (18 Feb. 2020) - Biostatisticians' Report<\/strong>:<\/p>\r\n - Current Accrual<\/strong><\/p>\r\n - IBCSG IDMC Memorandum<\/strong>:<\/p>\r\n - IBCSG EC Statements<\/strong>:<\/p>\r\n - SAE:<\/strong><\/p>\r\n <\/p>\r\n - Safety Reports<\/strong>:<\/p>\r\n Authorization Log<\/a> v1.0 (21 Feb18)<\/p>\r\n Investigator Site File Instrucions<\/a> v1.0 (March 23, 2022)<\/p>\r\n Investigators Site File Index<\/a> v2 (15 Oct 18)<\/p>\r\n Patient_screening_log<\/a> v1 (July 29, 2019)<\/p>\r\n Patient Pre-Screening<\/a> <\/a>Log v1.3<\/a><\/p>\r\n Training Slides<\/a> (July 2020) <\/p>\r\n Patient card DE v2.0<\/a> (Feb 2020) Patient Diary EN v1.2<\/a> (Febr 2018) Investigations and PR Labels Pathology Report Label Template<\/a> Let 5962 v1.0 (02 Jul 18) <\/p>\r\n Resources for Trial Participation CRFs: A Let<\/a> A4 (April 8, 2020) SAE-A Let<\/a> (Feb 20, 2018) For Monitors:<\/strong> Patient Deviation Log Procedures Document<\/a> v2.0 (March 8, 2018) <\/p>\r\n Trial Communications:<\/strong><\/p>\r\n Notification of End of Trial and Center Closure<\/a> (June 7, 2023)<\/p>\r\n DBF Communication<\/a> (April 6, 2023)<\/p>\r\n Enrollment Closure Letter<\/a> (Aug 3, 22)<\/p>\r\n IBCSG Merger Letter to Investigators<\/a> (March 9, 2022)<\/p>\r\n DIL<\/a> (Oct 24, 2019)<\/p>\r\n \"PALBOCICLIB ILD-IB Dear Investigator Letter_lung infections<\/a> (24 Oct 2019)<\/p>\r\n <\/p>\r\n Slide set TOUCH Investigator meeting<\/a> (Sept 27 2019)<\/p>\r\n <\/p>\r\n Volume 3, Issue 1<\/a> (December 2022) <\/p>\r\n Drug Supply Manual v5.0<\/a> (December 27, 2021)<\/p>\r\n Center Information Sheet<\/a> v3 (Feb 2, 2016)<\/p>\r\n General Obvious Corrections Document V2.0<\/a> (August 2015) Authorization Log Manual V3.0<\/a> (March 2011)<\/p>\r\n Appendix:<\/strong><\/p>\r\n TT USB Instructions<\/a> 1.0 <\/p>\r\n Data Managers Manual<\/a> v1 (Sept 2018)<\/p>\r\n {loadposition dfexplore}<\/p>\r\n {loadposition reg-rando-manual}<\/p>\r\n<\/div>","field53":"62"},"row3":{"field51":"Biological Material \/ Translational Research (Member)","field52":" {loadposition ffpe}<\/p>","field53":"62"},"row4":{"field51":"Biological Material \/ Translational Research","field52":" {loadposition biobank}<\/p>","field53":"1"},"row5":{"field51":"Results & Publications","field52":" Publications List <\/a>(December 2025)<\/p>","field53":"62"},"row6":{"field51":"Former Protocol Documents","field52":" <\/p>\r\n <\/p>\r\n <\/p>\r\n Amendment PIS\/IC:<\/p>\r\n Amendment PIS/IC: English v2.0 incl.GDPR (18 Feb 2020) PISIC Addendum: English v2.0 (18 Feb. 2020) Amendment PIS/IC: English v2.0 incl.GDPR (18 Feb 2020) PISIC Addendum: English v2.0 (18 Feb. 2020) - Biostatisticians' Report: - Current Accrual - IBCSG IDMC Memorandum: - IBCSG EC Statements: - SAE: - Safety Reports: - Biostatisticians' Report: - Current Accrual - IBCSG IDMC Memorandum: - IBCSG EC Statements: - SAE: - Safety Reports: Authorization Log v1.0 (21 Feb18) Investigator Site File Instrucions v1.0 (March 23, 2022) Investigators Site File Index v2 (15 Oct 18) Patient_screening_log v1 (July 29, 2019) Patient Pre-Screening Log v1.3 Training Slides (July 2020) Patient card DE v2.0 (Feb 2020) Patient Diary EN v1.2 (Febr 2018) Investigations and PR Labels Pathology Report Label Template Let 5962 v1.0 (02 Jul 18) Resources for Trial Participation CRFs: A Let A4 (April 8, 2020) SAE-A Let (Feb 20, 2018) Patient Deviation Log Procedures Document v2.0 (March 8, 2018) Trial Communications: Notification of End of Trial and Center Closure (June 7, 2023) DBF Communication (April 6, 2023) Enrollment Closure Letter (Aug 3, 22) IBCSG Merger Letter to Investigators (March 9, 2022) DIL (Oct 24, 2019) "PALBOCICLIB ILD-IB Dear Investigator Letter_lung infections (24 Oct 2019) Slide set TOUCH Investigator meeting (Sept 27 2019) Volume 3, Issue 1 (December 2022) Drug Supply Manual v5.0 (December 27, 2021) Center Information Sheet v3 (Feb 2, 2016) General Obvious Corrections Document V2.0 (August 2015) Authorization Log Manual V3.0 (March 2011) Appendix: TT USB Instructions 1.0 Data Managers Manual v1 (Sept 2018) Authorization Log v1.0 (21 Feb18) Investigator Site File Instrucions v1.0 (March 23, 2022) Investigators Site File Index v2 (15 Oct 18) Patient_screening_log v1 (July 29, 2019) Patient Pre-Screening Log v1.3 Training Slides (July 2020) Patient card DE v2.0 (Feb 2020) Patient Diary EN v1.2 (Febr 2018) Investigations and PR Labels Pathology Report Label Template Let 5962 v1.0 (02 Jul 18) Resources for Trial Participation CRFs: A Let A4 (April 8, 2020) SAE-A Let (Feb 20, 2018) Patient Deviation Log Procedures Document v2.0 (March 8, 2018) Trial Communications: Notification of End of Trial and Center Closure (June 7, 2023) DBF Communication (April 6, 2023) Enrollment Closure Letter (Aug 3, 22) IBCSG Merger Letter to Investigators (March 9, 2022) DIL (Oct 24, 2019) "PALBOCICLIB ILD-IB Dear Investigator Letter_lung infections (24 Oct 2019) Slide set TOUCH Investigator meeting (Sept 27 2019) Volume 3, Issue 1 (December 2022) Drug Supply Manual v5.0 (December 27, 2021) Center Information Sheet v3 (Feb 2, 2016) General Obvious Corrections Document V2.0 (August 2015) Authorization Log Manual V3.0 (March 2011) Appendix: TT USB Instructions 1.0 Data Managers Manual v1 (Sept 2018) {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} Publications List (December 2025) Publications List (December 2025) Amendment PIS/IC: Amendment PIS/IC: Trial Co-Chair Trial Coordinator Director of the Data Management Center Statistician Monitoring Final Accrual Date last patient was randomized Protocol Release Date Trial Activation Date First Patient In Accrual Closure Date Global Trial Completion Date Trial Co-Chair Trial Coordinator Director of the Data Management Center Statistician Monitoring Final Accrual Date last patient was randomized Protocol Release Date Trial Activation Date First Patient In Accrual Closure Date Global Trial Completion Date
French<\/a> v2.0 incl. GDPR (18 Feb 2020)
Italian<\/a> v2.0 incl. GDPR (18 Feb 2020)
Dutch<\/a> v2.0 incl. GDPR (18 Feb 2020)<\/p>\r\n
German<\/a> v2.0 (18 Feb 2020)
French<\/a> v2.0 (18 Feb 2020)
Italian<\/a> v2.0 (18 Feb 2020)
Dutch<\/a> v2.0 (18 Feb 2020)<\/p>","field53":"62"},"row1":{"field51":"Current Status","field52":"\r\n
\r\n
\r\n
\r\n
<\/a><\/li>\r\n<\/ul>\r\n\r\n
\r\n
Trial 55-17 TOUCH Specific Resources<\/h2>\r\n
Patient card FR v2.0<\/a> (Feb 2020)
Patient card IT v2.0<\/a> (Feb 2020)<\/p>\r\n
Patient Diary FR v1.1<\/a> (Feb 2018)
Patient Diary IT v1.1<\/a> (Feb 2018)<\/p>\r\n
<\/strong>Investigation Report Label Template<\/a> Let 5962 v1.0 (02 Jul 18)
Investigation Report Label Template<\/a> A4 3653 v2.0 (02 Jul 18)<\/p>\r\n
Pathology Report Label Template<\/a> A4 3653 v1.0 (02 Jul 18)<\/p>\r\n
<\/strong>
CTCAE v5 link<\/a>
<\/strong><\/p>\r\n
<\/strong>
G-CODE Italian<\/a> (Jan 30,2019)<\/p>\r\n
A Let A4 <\/a>(Feb 20, 2018)
SAE-A A4<\/a> (Feb 20, 2018)
SAE-B A4<\/a> (Feb 20, 2018)<\/p>\r\n
SAE-B Let<\/a> (Feb 20, 2018)
G8 Dutch Let<\/a> (Feb 20, 2018)
G8 French Let<\/a> (Feb 20, 2018)
G8 German Let<\/a> (Feb 20, 2018)
G8 Italian Let<\/a> (Feb 20, 2018)
G8 English Let<\/a> (Feb 20, 2018)
IADL Dutch Let<\/a> (Feb 20, 2018)
IADL French Let<\/a> (Feb 20, 2018)
IADL German Let<\/a> (Feb 20, 2018)
IADL Italian Let<\/a> (Feb 20, 2018)
IADL English Let<\/a> (Feb 20, 2018)
<\/p>\r\n
<\/a><\/p>\r\nPresentation<\/strong><\/h2>\r\n
TOUCH Flash<\/strong><\/h2>\r\n
Volume 2, Issue 2<\/a> (June, 2021)
Volume 2, Issue 1<\/a> (February 2021)
Volume 1, Issue 1<\/a> (August 2020)<\/p>\r\nGeneral Resources<\/h2>\r\n
<\/span><\/p>\r\n
<\/span><\/span>IMP Deviation Form PD103<\/a> v2.0
DF Palbociclib<\/a> 1.0
PCF Palbociclib<\/a> 1.0
DAL Palbociclib<\/a> 1.0
DAL Pertuzumab<\/a> 1.0
DAL Trastuzumab<\/a>1.0
DL Palbociclib<\/a> 1.0
DL Letrozole<\/a> 1.0
AL Paclitaxel<\/a> 1.0
DC Palbociclib<\/a> 1.0
DC Pertuzumab<\/a> 1.0
DC Trastuzumab<\/a> 1.0
TL Palbociclib<\/a> 1.0
TL Pertuzumab & Trastuzumab<\/a> 1.0<\/p>\r\nFFPE Tumor Tissue
Pathology Material Transfer Sheet<\/h2>\r\n\r\n
\r\nFFPE Material Shipment<\/h2>\r\n
Publications<\/h2>\r\n
Protocol<\/h2>\r\n
\r\n
Signature Page<\/a> v1.1 (21 Feb 2018)<\/li>\r\n\r\n
Principal Investigator Signature Page<\/a> v1.2 (5 Dec 2018)<\/div>\r\n<\/li>\r\n\r\n
English<\/a> v1.1 (21 Feb. 2018)
German<\/a> v1.1 (21 Feb. 2018)
French<\/a> v1.1 (21 Feb. 2018)
Italian<\/a> v1.1 (21 Feb. 2018)
Dutch<\/a> v1.1 (21 Feb. 2018)<\/li>\r\n<\/ul>\r\n
\r\nAppendices<\/h2>\r\n
\r\n
Protocol
Protocol v2.1 (12 June 2020)
Protocol v2.1 TC (12 June 2020)
Signature Page v2.1 (12 June 2020)
Signature Page v2.0 (18 Feb 2020)
Amendment 1 v2 (18 Feb 2020)
Amendment 1 v2 Summary of Changes (18 Feb 2020)
Principal Investigator Signature Page v2 (18 Feb 2020)
Amendment 1 v2 Summary of Changes (18 Feb 2020)
Amendment 1 v2 (18 Feb 2020)
Appendices
French v2.0 incl. GDPR (18 Feb 2020)
Italian v2.0 incl. GDPR (18 Feb 2020)
Dutch v2.0 incl. GDPR (18 Feb 2020)
German v2.0 (18 Feb 2020)
French v2.0 (18 Feb 2020)
Italian v2.0 (18 Feb 2020)
Dutch v2.0 (18 Feb 2020)Protocol
Protocol v2.1 (12 June 2020)
Protocol v2.1 TC (12 June 2020)
Signature Page v2.1 (12 June 2020)
Signature Page v2.0 (18 Feb 2020)
Amendment 1 v2 (18 Feb 2020)
Amendment 1 v2 Summary of Changes (18 Feb 2020)
Principal Investigator Signature Page v2 (18 Feb 2020)
Amendment 1 v2 Summary of Changes (18 Feb 2020)
Amendment 1 v2 (18 Feb 2020)
Appendices
French v2.0 incl. GDPR (18 Feb 2020)
Italian v2.0 incl. GDPR (18 Feb 2020)
Dutch v2.0 incl. GDPR (18 Feb 2020)
German v2.0 (18 Feb 2020)
French v2.0 (18 Feb 2020)
Italian v2.0 (18 Feb 2020)
Dutch v2.0 (18 Feb 2020)
Trial 55-17 TOUCH Specific Resources
Patient card FR v2.0 (Feb 2020)
Patient card IT v2.0 (Feb 2020)
Patient Diary FR v1.1 (Feb 2018)
Patient Diary IT v1.1 (Feb 2018)
Investigation Report Label Template Let 5962 v1.0 (02 Jul 18)
Investigation Report Label Template A4 3653 v2.0 (02 Jul 18)
Pathology Report Label Template A4 3653 v1.0 (02 Jul 18)
CTCAE v5 link
G-CODE Italian (Jan 30,2019)
A Let A4 (Feb 20, 2018)
SAE-A A4 (Feb 20, 2018)
SAE-B A4 (Feb 20, 2018)
SAE-B Let (Feb 20, 2018)
G8 Dutch Let (Feb 20, 2018)
G8 French Let (Feb 20, 2018)
G8 German Let (Feb 20, 2018)
G8 Italian Let (Feb 20, 2018)
G8 English Let (Feb 20, 2018)
IADL Dutch Let (Feb 20, 2018)
IADL French Let (Feb 20, 2018)
IADL German Let (Feb 20, 2018)
IADL Italian Let (Feb 20, 2018)
IADL English Let (Feb 20, 2018)Presentation
TOUCH Flash
Volume 2, Issue 2 (June, 2021)
Volume 2, Issue 1 (February 2021)
Volume 1, Issue 1 (August 2020)General Resources
IMP Deviation Form PD103 v2.0
DF Palbociclib 1.0
PCF Palbociclib 1.0
DAL Palbociclib 1.0
DAL Pertuzumab 1.0
DAL Trastuzumab1.0
DL Palbociclib 1.0
DL Letrozole 1.0
AL Paclitaxel 1.0
DC Palbociclib 1.0
DC Pertuzumab 1.0
DC Trastuzumab 1.0
TL Palbociclib 1.0
TL Pertuzumab & Trastuzumab 1.0
Trial 55-17 TOUCH Specific Resources
Patient card FR v2.0 (Feb 2020)
Patient card IT v2.0 (Feb 2020)
Patient Diary FR v1.1 (Feb 2018)
Patient Diary IT v1.1 (Feb 2018)
Investigation Report Label Template Let 5962 v1.0 (02 Jul 18)
Investigation Report Label Template A4 3653 v2.0 (02 Jul 18)
Pathology Report Label Template A4 3653 v1.0 (02 Jul 18)
CTCAE v5 link
G-CODE Italian (Jan 30,2019)
A Let A4 (Feb 20, 2018)
SAE-A A4 (Feb 20, 2018)
SAE-B A4 (Feb 20, 2018)
SAE-B Let (Feb 20, 2018)
G8 Dutch Let (Feb 20, 2018)
G8 French Let (Feb 20, 2018)
G8 German Let (Feb 20, 2018)
G8 Italian Let (Feb 20, 2018)
G8 English Let (Feb 20, 2018)
IADL Dutch Let (Feb 20, 2018)
IADL French Let (Feb 20, 2018)
IADL German Let (Feb 20, 2018)
IADL Italian Let (Feb 20, 2018)
IADL English Let (Feb 20, 2018)Presentation
TOUCH Flash
Volume 2, Issue 2 (June, 2021)
Volume 2, Issue 1 (February 2021)
Volume 1, Issue 1 (August 2020)General Resources
IMP Deviation Form PD103 v2.0
DF Palbociclib 1.0
PCF Palbociclib 1.0
DAL Palbociclib 1.0
DAL Pertuzumab 1.0
DAL Trastuzumab1.0
DL Palbociclib 1.0
DL Letrozole 1.0
AL Paclitaxel 1.0
DC Palbociclib 1.0
DC Pertuzumab 1.0
DC Trastuzumab 1.0
TL Palbociclib 1.0
TL Pertuzumab & Trastuzumab 1.0FFPE Tumor Tissue
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
Publications
Publications
Protocol
Signature Page v1.1 (21 Feb 2018)
Principal Investigator Signature Page v1.2 (5 Dec 2018)
English v1.1 (21 Feb. 2018)
German v1.1 (21 Feb. 2018)
French v1.1 (21 Feb. 2018)
Italian v1.1 (21 Feb. 2018)
Dutch v1.1 (21 Feb. 2018)
Appendices
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Signature Page v1.1 (21 Feb 2018)
Principal Investigator Signature Page v1.2 (5 Dec 2018)
English v1.1 (21 Feb. 2018)
German v1.1 (21 Feb. 2018)
French v1.1 (21 Feb. 2018)
Italian v1.1 (21 Feb. 2018)
Dutch v1.1 (21 Feb. 2018)
Appendices
Biological Material / Translational Research
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Laura Biganzoli, MD, Prato, Italy
Etienne Brain, MD, PhD, Paris, France
Meredith Kissel
Holly Shaw
Svitlana Tyekucheva
IBCSG Data Management Center/Frontier Science Foundation
4033 Maple Road
Amherst, New York 14226 USA
Phone: +1 716 834 0900
Fax: +1 716 833 3990
Email:
ETOP IBCSG Partners Foundation
Coordinating Center, Bern, Switzerland
Phone: +41 31 511 94 00
Fax: +41 31 511 94 01
Email:
Date of Activation
Feb 28, 2018
147
July 28, 2022
Feb 28, 2018
Oct 04, 2018
April 16, 2019
August 03, 2022
April 20, 2023
Laura Biganzoli, MD, Prato, Italy
Etienne Brain, MD, PhD, Paris, France
Meredith Kissel
Holly Shaw
Svitlana Tyekucheva
IBCSG Data Management Center/Frontier Science Foundation
4033 Maple Road
Amherst, New York 14226 USA
Phone: +1 716 834 0900
Fax: +1 716 833 3990
Email: ibcsg55_touch@frontierscience.org
ETOP IBCSG Partners Foundation
Coordinating Center, Bern, Switzerland
Phone: +41 31 511 94 00
Fax: +41 31 511 94 01
Email: TOUCH-monitoring@etop.ibcsg.org
Date of Activation
Feb 28, 2018
147
July 28, 2022
Feb 28, 2018
Oct 04, 2018
April 16, 2019
August 03, 2022
April 20, 2023
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
Contact
Phone: +41 31 511 94 00
E-mail: contact@etop.ibcsg.org