# 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

Source: https://onco.cc/trials/nct07498478/  
OnCo record `nct07498478` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Fulvestrant and Tinengotinib in HR-positive / HER2-negative breast cancer, run by TransThera Sciences (Nanjing), Inc., now recruiting.

## Summary

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 is a phase 2 interventional study registered as NCT07498478 by TransThera Sciences (Nanjing), Inc., with 94 participants planned, started 2026-03-17 and due to reach its primary completion in 2027-06-30. Interventions recorded: Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib and tinengotinib combined with fulvestrant.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07498478
- Phase: 2
- Setting: A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment
- Sponsor: TransThera Sciences (Nanjing), Inc.
- Enrolled: 94

## Sources

- ClinicalTrials.gov NCT07498478: https://clinicaltrials.gov/study/NCT07498478

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Tinengotinib](https://onco.cc/drugs/tinengotinib/)

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