Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON52884
NL-OMON52884
Completed
Phase 2

A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy - TIBET

BOOG Study Center0 sites50 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsER-positive breast cancerMetastatic breast cancerHer2 negative10006291

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
ER-positive breast cancer
Sponsor
BOOG Study Center
Enrollment
50
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
BOOG Study Center

Eligibility Criteria

Inclusion Criteria

  • •1\. Adult women(\>\= 18 years of age) with proven diagnosis of metastatic or
  • •locally advanced breast cancer not amenable to curative treatment by surgery or
  • •radiotherapy
  • •2\. Documented ER positive (10%) / PR positive (10%) and HER2 negative
  • •metastatic breast cancer
  • •3\. Progressive disease based on imaging
  • •4\. Women previously treated with capecitabine (in metastatic setting), and a
  • •maximum of two other lines of chemotherapy including a
  • •taxane either in the (neo)adjuvant or metastatic setting.
  • •5\. Evaluable disease as defined per RECIST v.1\.1 (see Appendix A). Tumor lesions

Exclusion Criteria

  • •1\. HER2\-overexpressing patients by local laboratory testing (IHC 3\+ staining or
  • •in situ hybridization positive) and ER\-negative patients are not eligible
  • •2\. No more than two lines of chemotherapy for advanced disease
  • •3\. Remaining of side\-effects from previous chemotherapy \> grade 1 (except for
  • •4\. Radiotherapy within four weeks prior to enrollment is not allowed except in
  • •case of localized radiotherapy for analgesic purpose or for lytic lesions at
  • •risk of fracture which can then be completed within two weeks prior to
  • •enrollment. Patients must have recovered from radiotherapy toxicities prior to
  • •enrollment.
  • •5\. 30% or more marrow\-bearing bone being irradiated. Other primary tumors

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 2
TAS102 in patients with ER-positive, HER2-negative advanced breast cancer (TIBET study)
2024-519204-27-00BOOG Study Center B.V.50
Recruiting
Phase 2
Phase II study of FTD/TPI plus RAM compared with FTD/TPI for advanced gastric cancer (WJOG15822G)
JPRN-jRCTs041220120Hiroki Hara110
Not yet recruiting
Phase 2
Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer.
NL-OMON56792niversitair Medisch Centrum Utrecht40
Recruiting
Phase 2
Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5- fluorouracile ± nivolumab in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer
2024-512999-35-00Unicancer118
Completed
Not Applicable
Retrospective study of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer(WJOG14520G)
JPRN-UMIN000044136West Japan Oncology Group140