TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Neoplasm
- Chemotherapy Effect
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multicenter, single arm, 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. 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
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. Objectives: To e...
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. 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 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 Taxanes is obligatory. Adequate hematology, liver and renal function tests.
Tracking Information
- NCT #
- NCT04489173
- Collaborators
- Erasmus Medical Center
- UMC Utrecht
- Servier
- BOOG Study Center
- Investigators
- Study Director: A. Elise van Leeuwen-Stok, PhD BOOG Study Center
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