Actively 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
Led by TransThera Sciences (Nanjing), Inc. · Updated on 2026-03-27
94
Participants Needed
13
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed breast cancer with local recurrence or distant metastasis not suitable for surgery or radiotherapy
- Breast cancer confirmed as HR-positive and HER2-negative or low expression based on recent tumor tissue sample
- Meet at least one of the following: prior bilateral oophorectomy or age 60 years or older; under 60 years with natural amenorrhea for 12 months and postmenopausal hormone levels; under 60 years receiving ovarian suppression therapy with postmenopausal hormone levels
- Previously failed 1-2 lines of endocrine therapy for recurrent or metastatic disease; initial diagnosis with weak ER positivity (1%-10%) not eligible
- Experienced disease progression after prior treatment with at least one CDK4/6 inhibitor
- Previously failed 0-2 lines of systemic chemotherapy for recurrent or metastatic disease (ADCs not counted)
- ECOG performance status 0 or 1
- Meet RECIST v1.1 criteria with at least one measurable lesion or certain bone lesions
- Adequate organ and bone marrow function
- Premenopausal participants receiving ovarian suppression must agree to use adequate contraception during and for 3 months after treatment
- Able to sign informed consent and comply with study protocol
You will not qualify if you...
- Pregnant or breastfeeding women
- History of severe allergy to study drug components, prior treatment with the study drug, or life-threatening complications like uncontrollable effusions
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- Brain or central nervous system metastases progressing within 28 days before treatment
- Concurrent progressing malignancies requiring active treatment (except certain non-invasive or cured tumors)
- Recent systemic corticosteroid or immunosuppressive therapy within 14 days before study drug
- Recent systemic anti-tumor therapy or investigational drug use within washout period
- Extensive radiotherapy or major surgery within 4 weeks or local palliative radiotherapy within 2 weeks before study drug
- Not recovered from prior anti-tumor therapy adverse events beyond specified grades
- History of severe cardiac or cerebrovascular disease
- Severe gastrointestinal disease affecting drug absorption or metabolism
- Bleeding or thrombotic disorders requiring anticoagulant therapy with INR monitoring
- Use of strong CYP3A inhibitors or inducers within 2 weeks or 5 half-lives before study drug
- Positive test for HIV
- Active hepatitis B or C infection
- Unable to swallow or tolerate oral medication
- Investigator judgment of other reasons making participant unsuitable for the study
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
4
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
5
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
6
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
7
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
8
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
9
Beijing Cancer Hospital
Beijing, China
Not Yet Recruiting
10
The First Medical Center, Chinese PLA General Hospital
Beijing, China
Not Yet Recruiting
11
Southwest Hospital
Chongqing, China
Not Yet Recruiting
12
Fudan University Shanghai Cancer Center
Shanghai, China
Not Yet Recruiting
13
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Not Yet Recruiting
Research Team
C
Caixia Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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