OncoMatch/Clinical Trials/NCT07498478
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 NCT07498478 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tinengotinib at the optimal dose combined with Fulvestrant and Tinengotinib for breast cancer.
Treatment: Tinengotinib at the optimal dose combined with Fulvestrant · Tinengotinib · tinengotinib combined with fulvestrant — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive expression (HR-positive as defined by CSCO 2024 criteria)
Breast cancer confirmed as HR+/HER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample
Required: HER2 (ERBB2) negative or low expression (HER2-negative or low expression as defined by CSCO 2024 criteria)
Breast cancer confirmed as HR+/HER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample
Disease stage
Metastatic disease required
local recurrence or distant metastasis and no indication for surgery or radiotherapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy (aromatase inhibitor, SERD, SERM) — recurrent or metastatic
Participants who have previously failed 1-2 lines of endocrine therapy (including AI, SERD, and SERM) for recurrent or metastatic disease
Must have received: CDK4/6 inhibitor
Participants must have experienced disease progression after prior treatment with at least one CDK4/6 inhibitor (CDK4/6i), including in the neoadjuvant, adjuvant, or systemic treatment settings
Lab requirements
Blood counts
adequate bone marrow function required
Kidney function
adequate organ function required
Liver function
adequate organ function required
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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