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 Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA).
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 Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA).
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Protocol<\/h2>\r\n
\r\n
Protocol version 6.0 dated 11 August 2025<\/a><\/li>\r\n
Summary of the protocol in French version 6.0 dated 11 August 2025<\/a><\/li>\r\n
Summary of the protocol in German version 6.0 dated 11 August 2025<\/a><\/li>\r\n
Summary of the protocol in Italian version 6.0 dated 11 August 2025<\/a><\/li>\r\n<\/ul>\r\n
Appendices<\/h2>\r\n
 <\/p>\r\n
Previous Protocol<\/h2>\r\n
\r\n
Protocol version 5.0_20250217<\/a> <\/li>\r\n
Summary of the protocol in French version 5.0 dated 17 February 2025 <\/a><\/li>\r\n
Summary of the protocol in German version 5.0 dated 17 February 2025 <\/a><\/li>\r\n
Summary of the protocol in Italian version 5.0 dated 17 February 2025<\/a><\/li>\r\n
Protocol version 4.0_20241204<\/a><\/li>\r\n
Protocol version 3.0 dated 13 October 2023<\/a><\/li>\r\n
Summary of the protocol in French version 3.0 dated 13 October 2023<\/a><\/li>\r\n
Summary of the protocol in German version 3.0 dated 13 October 2023<\/a><\/li>\r\n
Summary of the protocol in Italian version 3.0 dated 13 October 2023<\/a><\/li>\r\n<\/ul>","field53":"74"},"row1":{"field51":"Current Status","field52":"
Current Accrual:<\/strong><\/p>\r\n
 <\/p>\r\n
SAE:<\/strong><\/p>\r\n
 <\/p>\r\n
Biostatisticians' Report<\/strong>:<\/p>\r\n
 <\/p>\r\n
 <\/p>","field53":"74"},"row2":{"field51":"Data Management Resources","field52":"
2129-BCG Treat ctDNA Specific Resources

<\/h2>\r\n
EORTC Study Documentation Portal <\/a><\/p>\r\n
 <\/p>\r\n
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in English<\/a>
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in French<\/a>
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in German<\/a>
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in Italian<\/a>
Patient diary anastrozole in French version 1.0<\/a> dated 09 June 2022
Patient diary anastrozole in German version 1.0<\/a> dated 09 June 2022
Patient diary anastrozole in Italian version 1.0<\/a> dated 09 June 2022
Patient diary elacestrant in French version 1.0<\/a> dated 09 June 2022
Patient diary elacestrant in German version 1.0<\/a> dated 09 June 2022
Patient diary elacestrant in Italian version 1.0<\/a> dated 09 June 2022
Patient diary exemestane in French version 1.0<\/a> dated 09 June 2022
Patient diary exemestane in German version 1.0<\/a> dated 09 June 2022
Patient diary exemestane in Italian version 1.0<\/a> dated 09 June 2022
Patient diary letrozole in French version 1.0<\/a> dated 09 June 2022
Patient diary letrozole in German version 1.0<\/a> dated 09 June 2022
Patient diary letrozole in Italian version 1.0<\/a> dated 09 June 2022
Patient diary tamoxifen in French version 1.0<\/a> dated 09 June 2022
Patient diary tamoxifen in German version 1.0<\/a> dated 09 June 2022
Patient diary tamoxifen in Italian version 1.0<\/a> dated 09 June 2022
Example of the label for Elacestrant 100 mg in French<\/a>
Example of the label for Elacestrant 100 mg in German<\/a>
Example of the label for Elacestrant 100 mg in Italian<\/a>
Example of the label for Elacestrant 400 mg in French<\/a>
Example of the label for Elacestrant 400 mg in German<\/a>
Example of the label for Elacestrant 400 mg in Italian<\/a>
ISF index v1.0 20230828<\/a> <\/p>\r\n
 <\/p>","field53":"74"},"row3":{"field51":"Pathology","field52":"","field53":"74"},"row4":{"field51":"Results & Publications","field52":"
 <\/h2>","field53":"74"}}"
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Protocol

Protocol version 6.0 dated 11 August 2025
Summary of the protocol in French version 6.0 dated 11 August 2025
Summary of the protocol in German version 6.0 dated 11 August 2025
Summary of the protocol in Italian version 6.0 dated 11 August 2025

Appendices
 
Previous Protocol

Protocol version 5.0_20250217 
Summary of the protocol in French version 5.0 dated 17 February 2025 
Summary of the protocol in German version 5.0 dated 17 February 2025 
Summary of the protocol in Italian version 5.0 dated 17 February 2025
Protocol version 4.0_20241204
Protocol version 3.0 dated 13 October 2023
Summary of the protocol in French version 3.0 dated 13 October 2023
Summary of the protocol in German version 3.0 dated 13 October 2023
Summary of the protocol in Italian version 3.0 dated 13 October 2023
"
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Protocol

Protocol version 6.0 dated 11 August 2025
Summary of the protocol in French version 6.0 dated 11 August 2025
Summary of the protocol in German version 6.0 dated 11 August 2025
Summary of the protocol in Italian version 6.0 dated 11 August 2025

Appendices
 
Previous Protocol

Protocol version 5.0_20250217 
Summary of the protocol in French version 5.0 dated 17 February 2025 
Summary of the protocol in German version 5.0 dated 17 February 2025 
Summary of the protocol in Italian version 5.0 dated 17 February 2025
Protocol version 4.0_20241204
Protocol version 3.0 dated 13 October 2023
Summary of the protocol in French version 3.0 dated 13 October 2023
Summary of the protocol in German version 3.0 dated 13 October 2023
Summary of the protocol in Italian version 3.0 dated 13 October 2023
"
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SAE:
 
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2129-BCG Treat ctDNA Specific Resources


EORTC Study Documentation Portal 
 
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in English
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in French
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in German
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in Italian
Patient diary anastrozole in French version 1.0 dated 09 June 2022
Patient diary anastrozole in German version 1.0 dated 09 June 2022
Patient diary anastrozole in Italian version 1.0 dated 09 June 2022
Patient diary elacestrant in French version 1.0 dated 09 June 2022
Patient diary elacestrant in German version 1.0 dated 09 June 2022
Patient diary elacestrant in Italian version 1.0 dated 09 June 2022
Patient diary exemestane in French version 1.0 dated 09 June 2022
Patient diary exemestane in German version 1.0 dated 09 June 2022
Patient diary exemestane in Italian version 1.0 dated 09 June 2022
Patient diary letrozole in French version 1.0 dated 09 June 2022
Patient diary letrozole in German version 1.0 dated 09 June 2022
Patient diary letrozole in Italian version 1.0 dated 09 June 2022
Patient diary tamoxifen in French version 1.0 dated 09 June 2022
Patient diary tamoxifen in German version 1.0 dated 09 June 2022
Patient diary tamoxifen in Italian version 1.0 dated 09 June 2022
Example of the label for Elacestrant 100 mg in French
Example of the label for Elacestrant 100 mg in German
Example of the label for Elacestrant 100 mg in Italian
Example of the label for Elacestrant 400 mg in French
Example of the label for Elacestrant 400 mg in German
Example of the label for Elacestrant 400 mg in Italian
ISF index v1.0 20230828 
 
"
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2129-BCG Treat ctDNA Specific Resources


EORTC Study Documentation Portal 
 
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in English
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in French
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in German
EORTC QLQ-C30, QLQ-BR42 and IL46 questionnaire in Italian
Patient diary anastrozole in French version 1.0 dated 09 June 2022
Patient diary anastrozole in German version 1.0 dated 09 June 2022
Patient diary anastrozole in Italian version 1.0 dated 09 June 2022
Patient diary elacestrant in French version 1.0 dated 09 June 2022
Patient diary elacestrant in German version 1.0 dated 09 June 2022
Patient diary elacestrant in Italian version 1.0 dated 09 June 2022
Patient diary exemestane in French version 1.0 dated 09 June 2022
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Patient diary exemestane in Italian version 1.0 dated 09 June 2022
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Patient diary letrozole in Italian version 1.0 dated 09 June 2022
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Patient diary tamoxifen in German version 1.0 dated 09 June 2022
Patient diary tamoxifen in Italian version 1.0 dated 09 June 2022
Example of the label for Elacestrant 100 mg in French
Example of the label for Elacestrant 100 mg in German
Example of the label for Elacestrant 100 mg in Italian
Example of the label for Elacestrant 400 mg in French
Example of the label for Elacestrant 400 mg in German
Example of the label for Elacestrant 400 mg in Italian
ISF index v1.0 20230828 
 
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