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Study identifier: NCT07498478 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Breast Cancer  ·  Sponsor: TransThera Sciences (Nanjing), Inc.

PhasePhase 2
Planned participants94
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.

This description comes directly from the study's public registry record.

Talk to the study team

Caixia Sun  ·  025-58216298  ·  sun_caixia@transtherabio.com

Always discuss trial participation with your own doctor first.

Locations (13)

Guangdong Provincial People's HospitalGuangzhou, Guangdong, ChinaNot Yet Recruiting
Zhongnan Hospital of Wuhan UniversityWuhan, Hubei, ChinaNot Yet Recruiting
Hunan Cancer HospitalChangsha, Hunan, ChinaNot Yet Recruiting
Jiangsu Province HospitalNanjing, Jiangsu, ChinaNot Yet Recruiting
Shandong Cancer HospitalJinan, Shandong, ChinaNot Yet Recruiting
Linyi Cancer HospitalLinyi, Shandong, ChinaRecruiting
Zhejiang Cancer HospitalHangzhou, Zhejiang, ChinaNot Yet Recruiting
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
Beijing Cancer HospitalBeijing, ChinaNot Yet Recruiting
The First Medical Center, Chinese PLA General HospitalBeijing, ChinaNot Yet Recruiting
Southwest HospitalChongqing, ChinaNot Yet Recruiting
Fudan University Shanghai Cancer CenterShanghai, ChinaNot Yet Recruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07498478