Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are: 1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants? 2. What medical problems do participants have when taking the combination therapy? Participants will: Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A. In

Trial Details

NCT ID
NCT07498478
Phase
PHASE2
Sponsor
TransThera Sciences (Nanjing), Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Tinengotinib at the optimal dose combined with Fulvestrant
  • Tinengotinib
  • tinengotinib combined with fulvestrant
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Wuhan, Hubei, China|30.58333,114.26667
  • Changsha, Hunan, China|28.19874,112.97087
  • Nanjing, Jiangsu, China|32.06167,118.77778
  • Jinan, Shandong, China|36.66833,116.99722

Key Eligibility Criteria

  • Histologically or cytologically confirmed breast cancer with evidence of local recurrence or distant metastasis and no indication for surgery or ra…
  • Breast cancer confirmed as HR+/HER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample (from eith…
  • Participants must meet at least one of the following criteria: a) prior bilateral oophorectomy, or age ≥60 years; b) age \<60 years, with natural a…
  • Participants who have previously failed 1-2 lines of endocrine therapy (including AI, SERD, and SERM) for recurrent or metastatic disease are eligi…

For full eligibility, visit ClinicalTrials.gov.

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