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 | 51 | ||||
| Actual accrual | 49 | Date: 30-04-2023 | |||
| Estimated study completion date | 01-09-2023 | ||||
| CCMO approval | Yes | Date: 24-07-2019 | Nr: NL69646.078.19 | ||
| EudraCT nr. | 2019-001706-15 | ||||
| Trial Register | NCT04489173 | ||||
| METC approval | Yes | Date: 29-07-2020 | METC: Erasmus Medisch Centrum Rotterdam | Nr: MEC-2019-0468 | |
| Amendments | Yes | Date: 07-05-2021 | |||
| 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: Tatjana Westphal e: trialbureau@iknl.nl t: 088 234 6500 |
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| Monitoring | IKNL Clinical Research Department Monitor : Rogier Pullens e: monitor@iknl.nl t: 088 234 6500 |
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| Local datamanagement | IKNL Clinical Research Department e: trialbureau@iknl.nl t: 088 234 6500 |
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| Funding | Servier | |||
| Extra | ||||
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.
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 a taxane and capecitabine
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
Metastatic Her2 negative, ER-positive breast cancer patients that progressed on, or after treatment with Capecitabine. Previous treatment with Taxanes is obligatory. Adequate hematology, liver and renal function tests.
Deelnemende ziekenhuizen:
Open voor inclusie:
Amphia Ziekenhuis
Catharina Ziekenhuis
Deventer Ziekenhuis
Erasmus MC
Medisch Centrum Leeuwarden
Maastricht UMC+
Reinier de Graaf Gasthuis
Rijnstate Ziekenhuis
UMC Utrecht
Wilhelmina Ziekenhuis Assen
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