Studieoverzicht - 2019-01 TIBET

 
Number 2019-01 TIBET
Nickname TIBET
Status Open Date: 25-09-2020
Inclusion closed
Other study number(s)
Participating parties/groups
Full title A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy
Phase and type Non-randomized Phase II
Age >18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 50
Actual accrual 1 Date: 27-10-2020
Estimated study completion date 31-12-2021
CCMO approval Yes Date: 24-07-2019 Nr: NL69646.078.19
EudraCT nr. 2019-001706-15
Trial Register NCT04489173
METC approval Yes Date: 22-01-2020 METC: Erasmus Medisch Centrum Rotterdam Nr: MEC-2019-0468
Amendments Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website , voor patienten: https://www.kanker.nl/trials/1119-tibet-studie-borstkanker
Sponsor BOOG
Principal Investigator(s) Dr. M.M.E.M. Bos (ErasmusMC), Dr. R.M. Bijlsma (UMCU)
Study manager Dr. A.E. van Leeuwen-Stok (BOOG Study Center)
Central datamanagement and randomization IKNL Clinical Research Department
Central Data Manager: Linda Mol
e: trialbureau@iknl.nl
t: 088 234 6500
Monitoring IKNL Clinical Research Department
Monitor : Rogier Pullens
e: monitor@iknl.nl
t: 088 234 6500
Local datamanagement IKNL Clinical Research Department
e: trialbureau@iknl.nl
t: 088 234 6500
Funding Servier
Extra

Design:

This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. This study will be conducted under the sponsorship of BOOG, Amsterdam, NL. 

Study medication should be started within 3 days after completion of screening and continue until a study treatment discontinuation criterion is met. 

Trifluridine/tipiracil will be administered orally BID on days 1 through 5, with the first dose administered in the morning of day 1 of each cycle and the last dose administered in the evening of day 5, followed by a recovery period from day 6 through day 7. Trifluridine/tipiracil will be administered orally BID on days 8 through 12, with the first dose administered in the morning of day 8 of each cycle and the last dose administered in the evening of day 12, followed by a recovery period from day 13 through day 28. Each cycle will be 28 days. 

 

Objectives:

To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with an anthracycline, a taxane and capecitabine 

 

 

 

Endpoints:

Progression-free survival 

  • Response rate CR/PR at 16 weeks 
  • Adverse events 
  • Translational research on biological factors that may be of influence on the outcome of treatment 
  • QoL 
Main eligibility criteria:

Metastatic Her2 negative, ER-positive breast cancer patients that progressed on, or after treatment with Capecitabine. Previous treatment with antracyclines and Taxanes is obligatory. Adequate hematology, liver and renal function tests.

Documents (public):

Deelnemende ziekenhuizen:

 

 

Open voor inclusie:                                     Nog niet open voor inclusie:

Amphia Ziekenhuis                                        Catharina Ziekenhuis

Deventer Ziekenhuis                                      Rijnstate Ziekenhuis

Erasmus MC                                                  Zuyderland

Medisch Centrum Leeuwarden                     

Maastricht UMC+                                          

Reinier de Graaf Gasthuis      

UMC Utrecht                      

 

 

 

 

 

 

Documents (protected):
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