Breast CancerPhase 2NCT07498478
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
A Phase 2 study testing Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib and tinengotinib combined with fulvestrant in people with Breast Cancer, run by TransThera Sciences (Nanjing), Inc. at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib and tinengotinib combined with fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 13 sitesChina
- Study dates
- 17 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed breast cancer with evidence of local recurrence or distant metastasis and no indication for surgery or radiotherapy;
- Breast cancer confirmed as HR+/HER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample (from either the primary or metastatic site, excluding bone lesions). HR-positive, HER2-negative or low expression as defined in this study refer to the Chinese Society of Clinical Oncology [CSCO] 2024 criteria;
- Participants must meet at least one of the following criteria: a) prior bilateral oophorectomy, or age ≥60 years; b) age <60 years, with natural amenorrhea (in the absence of medication or pathological conditions) for ≥12 months, and estradiol and FSH levels within the postmenopausal range; c) age <60 years, currently undergoing ovarian suppression therapy (e.g., LHRH agonist) and requiring continued treatment during the study, with estradiol and FSH levels maintained within the postmenopausal range;
- Participants who have previously failed 1-2 lines of endocrine therapy (including AI, SERD, and SERM) for recurrent or metastatic disease are eligible. Subjects with initial diagnosis showing weak ER positivity by IHC (tumor cells with nuclear staining accounting for 1%-10%) are not eligible for enrollment;
- 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;
- Participants who have previously failed 0-2 lines of systemic chemotherapy (cytotoxic drugs) for recurrent or metastatic disease. Antibody-drug conjugates (ADCs) are not counted as systemic chemotherapy;
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- ECOG ≤ 1;
- Participants must meet at least one of the following criteria (per RECIST v1.1): a) At least one measurable lesion as defined by RECIST v1.1 at baseline; if the only target lesion is a non-nodal lesion, its longest diameter must be ≥15 mm; b) When bone lesions are the only measurable lesions, lytic or mixed bone lesions may be selected as target lesions; subjects with only blastic bone lesions are not eligible for enrollment.
- Adequate organ and bone marrow function;
- Premenopausal participants receiving ovarian suppression therapy must agree to use adequate contraception to avoid pregnancy during the study and for at least 3 months after the end of treatment;
- Able to sign informed consent and comply with the protocol.
Who cannot join
- Participants who are pregnant or breastfeeding;
- Conditions judged by the investigator as making the participant unsuitable for study drug treatment, including but not limited to: a history of severe allergy to the components or excipients of the study drug, prior treatment history with the study drug, or presence of complications that may be life-threatening in the short term (such as pleural, pericardial, or abdominopelvic effusions that cannot be controlled by drainage or other methods);
- Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg), allowing for the lowest value from up to two repeat measurements;
- Participants with brain or central nervous system (CNS) metastases that have progressed as confirmed by imaging or clinically within 28 days before the start of treatment (e.g., evidence of new or enlarging brain metastases on imaging, new neurological symptoms attributable to brain/CNS metastases);
- Participants with concurrent other malignancies or hematologic malignancies that are progressing or require active treatment (excluding basal cell carcinoma of the skin, other non-invasive or indolent malignancies, or cured tumors); Hormone replacement therapy is permitted (e.g., thyroxine replacement therapy post-thyroidectomy);
- Participants who have received systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive medications within 14 days prior to the initiation of the study drug;
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- Participants who have received other systemic anti-tumor therapies or treatment with investigational drugs prior to the initiation of the study drug, with a washout period of approximately 5 half-lives or 14 days, whichever is shorter;
- Participants who have received extensive radiotherapy or major surgery within 4 weeks prior to the initiation of the study drug, or local palliative radiotherapy within 2 weeks. (If the investigator judges that this does not pose an additional safety risk, initiation of the study drug during the washout period may be permitted with sponsor agreement.)
- Participants who have not yet recovered from adverse events resulting from prior anti-tumor therapy (excluding adverse events ≤ Grade 1 per CTCAE, or ≤ Grade 2 adverse events that the investigator judges do not pose a safety risk).
- History of severe cardiac or cerebrovascular disease;
- Participants who have severe gastrointestinal disease or gastrointestinal dysfunction that may lead to absorption, metabolism or excretion of the study drug, enrollment eligibility will be based on the investigator's judgment (including but not limited to total gastrotomy, short bowel syndrome).
- Participants who have bleeding disorders or thrombotic disorders or therapeutic anticoagulant therapy requiring INR monitoring.
- Participants who have received a strong CYP3A inhibitor and inducer before starting the study drug, within an interval of ≤ 2 weeks or 5 half-lives (whichever is shorter);
- Tested positive for the human immunodeficiency virus (HIV);
- Participants with active HBV infection and/or HCV infection;
- Participants who are unable to swallow or tolerate oral medication.
- The investigator determines that there are other reasons making the participant unsuitable for participation in the study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Binghe Xu, MD
- Not yet recruiting
Beijing Cancer Hospital
Beijing
Huiping Li, MD
- Not yet recruiting
The First Medical Center, Chinese PLA General Hospital
Beijing
Weihong Zhao, MD
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Quchang Ouyang, MD
- Not yet recruiting
Southwest Hospital
Chongqing
Yi Zhang, MD
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Kun Wang, MD
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Hai Hu, MD
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong
Huihui Li, MD
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong
Guozhu Liu, MD
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Yongmei Yin, MD
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai
Hongxia Wang, MD
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Zhongsheng Tong, MD
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Haijun Yu, MD
About this study
Official title: 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
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:
- Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?
- What medical problems do participants have when taking the combination therapy?
Read more
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
- Breast Cancer
- Being tested
- Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib, tinengotinib combined with fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinengotinib at the optimal dose combined with FulvestrantDrug
Participants will receive tinengotinib at the optimal dose once daily with fulvestrant in 28-day cycles per protocol defined schedule.
TinengotinibDrug
Participants will receive tinengotinib once daily in 28-day cycles per protocol defined schedule.
tinengotinib combined with fulvestrantDrug
Participants will take tinengotinib at the starting dose of 10 mg once daily with fulvestrant to determine the optimal dose of tinengotinib in combination with fulvestrant. If not tolerated, the dose of tinengotinib will be reduced to 8 mg or 6 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Part B (combination therapy) | Experimental | Not described Receives: Drug: Tinengotinib at the optimal dose combined with Fulvestrant |
| Part B (monotherapy therapy) | Experimental | Not described Receives: Drug: Tinengotinib |
| Part A (dose optimization) | Experimental | Not described Receives: Drug: tinengotinib combined with fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: safety evaluation parameters
Including incidence, duration, and severity of DLTs and treatment-related adverse events (TRAEs)
Measured: From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.
Part B: Objective Response Rate (ORR) (RECIST v1.1)
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Measured: From first study drug administration to the end of treatment, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start17 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498478
- Sponsor's protocol ID
- TT00420CN15
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07498478
- Acronym / sponsor ID
- TT00420CN15
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part B (combination therapy) | Experimental | Drug: Tinengotinib at the optimal dose combined with Fulvestrant |
| Part B (monotherapy therapy) | Experimental | Drug: Tinengotinib |
| Part A (dose optimization) | Experimental | Drug: tinengotinib combined with fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed breast cancer with evidence of local recurrence or distant metastasis and no indication for surgery or radiotherapy;
- Breast cancer confirmed as HR+/HER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample (from either the primary or metastatic site, excluding bone lesions). HR-positive, HER2-negative or low expression as defined in this study refer to the Chinese Society of Clinical Oncology [CSCO] 2024 criteria;
- Participants must meet at least one of the following criteria: a) prior bilateral oophorectomy, or age ≥60 years; b) age <60 years, with natural amenorrhea (in the absence of medication or pathological conditions) for ≥12 months, and estradiol and FSH levels within the postmenopausal range; c) age <60 years, currently undergoing ovarian suppression therapy (e.g., LHRH agonist) and requiring continued treatment during the study, with estradiol and FSH levels maintained within the postmenopausal range;
- Participants who have previously failed 1-2 lines of endocrine therapy (including AI, SERD, and SERM) for recurrent or metastatic disease are eligible. Subjects with initial diagnosis showing weak ER positivity by IHC (tumor cells with nuclear staining accounting for 1%-10%) are not eligible for enrollment;
- 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;
Key exclusion criteria (17 listed)
- Participants who are pregnant or breastfeeding;
- Conditions judged by the investigator as making the participant unsuitable for study drug treatment, including but not limited to: a history of severe allergy to the components or excipients of the study drug, prior treatment history with the study drug, or presence of complications that may be life-threatening in the short term (such as pleural, pericardial, or abdominopelvic effusions that cannot be controlled by drainage or other methods);
- Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg), allowing for the lowest value from up to two repeat measurements;
- Participants with brain or central nervous system (CNS) metastases that have progressed as confirmed by imaging or clinically within 28 days before the start of treatment (e.g., evidence of new or enlarging brain metastases on imaging, new neurological symptoms attributable to brain/CNS metastases);
- Participants with concurrent other malignancies or hematologic malignancies that are progressing or require active treatment (excluding basal cell carcinoma of the skin, other non-invasive or indolent malignancies, or cured tumors); Hormone replacement therapy is permitted (e.g., thyroxine replacement therapy post-thyroidectomy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinengotinib at the optimal dose combined with FulvestrantParticipants will receive tinengotinib at the optimal dose once daily with fulvestrant in 28-day cycles per protocol defined schedule. | Drug | Part B (combination therapy) |
| TinengotinibParticipants will receive tinengotinib once daily in 28-day cycles per protocol defined schedule. | Drug | Part B (monotherapy therapy) |
| tinengotinib combined with fulvestrantParticipants will take tinengotinib at the starting dose of 10 mg once daily with fulvestrant to determine the optimal dose of tinengotinib in combination with fulvestrant. If not tolerated, the dose of tinengotinib will be reduced to 8 mg or 6 mg once daily. | Drug | Part A (dose optimization) |
Primary outcome
Part A: safety evaluation parameters
Time frame: From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.
Including incidence, duration, and severity of DLTs and treatment-related adverse events (TRAEs)
Part B: Objective Response Rate (ORR) (RECIST v1.1)
Time frame: From first study drug administration to the end of treatment, an average of 1 year.
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib and tinengotinib combined with fulvestrant in people with Breast Cancer, run by TransThera Sciences (Nanjing), Inc. at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caixia Sun (025-58216298, sun_caixia@transtherabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: safety evaluation parameters (time frame: From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.