Breast CancerPhase 2NCT05186545
An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer
A Phase 2 study testing surufatinib + fulvestrant + chidamide in people with Breast Cancer and Breast Cancer Female, run by The First Affiliated Hospital of Zhengzhou University at 5 sites in China.
Trial summary
This is a prospective, single center, single arm phase II study designed to explore the efficacy and safety of surufatinib + fulvastrant + chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female
- What is being tested?
- surufatinib + fulvestrant + chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2022to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the Informed Consent Form;
- 18-75 Years (concluding 18 and 75 Years), female;
- Pathologically and cytologically confirmed non-resectable stage IV Her2 negative, HR positive (ER+ and / or PR+) breast cancer;
- Relapsed or progressed after at least first-line endocrine therapy, with patients of primary endocrine resistance excluded (patients of recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy are eligible; patients progressed more than 1 year but less than 2 years after adjuvant endocrine therapy are not eligible);
- 2 weeks or more from the last endocrine therapy and 3 weeks or more from the last chemotherapy before enrollment;
- At least one measurable lesion is required;
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- Life expectancy greater than 3 months;
- ECOG(Eastern Cooperative Oncology Group): 0~1;
- Sufficient organ and bone marrow functions as follows:
- Absolute Neutrophil Count (ANC) ≥1.5×10^9/L; Platelet Count of ≥100×10^9/L; Hemoglobin≥90g/L; Total Bilirubin (TBIL)<1.5 x ULN; ALT and AST<1.5 x ULN; Serum Creatinine (SCr)<1.5×ULN; Endogenous creatinine clearance rate ≥50ml / min (Cockcroft Gault formula)
Who cannot join
- Previous treatment with VEGFR inhibitor, HDAC inhibitor or fulvestrant;
- Organ surgery performed 6 weeks before enrollment;
- A history of other malignancies within 5 years prior to enrollment, except for cervical carcinoma in situ, basal or squamous cell skin cancer;
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
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- Poorly controlled diabetes before enrollment;
- Clinically significant electrolyte abnormalities judged by researchers;
- With any diseases or conditions that affected drug absorption, or the patient could not take drugs orally;
- Patients with obvious evidence of bleeding tendency or medical history or hemoptysis within 3 months before enrollment, thromboembolism within 12 months;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）;
- History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10^3/m);
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Anyang Tumor Hospital
Anyang
Jing Sun
- Recruiting
Henan University of Science and Technology First Affiliated Hospital
Luoyang
Xinshuai Wang
- Not yet recruiting
Nanyang Second General Hospital
Nanyang
Lina Liu
- Recruiting
He'nan Cancer Hospital
Zhengzhou
Hongqiang Guo
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou
Lige Yao
About this study
Official title: An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer Refractory to Endocrine Therapy
This is a prospective, single center, single arm phase II study designed to explore the efficacy and safety of surufatinib + fulvastrant + chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy.
Read the detailed description
This is a prospective, single center, single arm phase II study. In the safety lead-in stage, 6 subjects will be recruited and administered with surufatinib 250 mg/d, QD PO; Fulvestrant 500mg, im, Q4W; Chidamide 30mg, PO, BIW, with four weeks as a cycle. DLTs of the 6 subjects will be evaluated in the first cycle to determine the recommended dosage of combinational therapy. Then 57 subjects will be recruited and administered with the triplet regimen to explore the efficacy and safety of combinational treatment.
- Conditions
- Breast Cancer, Breast Cancer Female
- Being tested
- surufatinib + fulvestrant + chidamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinib + fulvestrant + chidamideDrug
surufatinib: 250 mg/d, QD PO; Fulvestrant: 500mg, im, Q4W; Chidamide 30mg, PO, BIW; Q4W
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | surufatinib + fulvestrant + chidamide Receives: Drug: surufatinib + fulvestrant + chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Measured: up to 3 years
Secondary outcomes (4)
ORR
The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart.
Measured: up to 3 years
DCR
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD).
Measured: up to 3 years
OS
The time from recruitment to death due to any cause.
Measured: up to 3 years
Adverse Events (AEs)
Adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jul 2022
- Primary completionJan 2024 (estimated)
- Study completionJul 2025 (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.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Zong, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186545
- Sponsor's protocol ID
- HMPL-012-SPRING-R101
- Status last verified
- Aug 2022
- First submitted
- 23 Dec 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer Refractory to Endocrine Therapy
- ClinicalTrials.gov ID
- NCT05186545
- Acronym / sponsor ID
- HMPL-012-SPRING-R101
- Conditions
- Breast Cancer, Breast Cancer Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Jan 2022 (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.
This is a prospective, single center, single arm phase II study designed to explore the efficacy and safety of surufatinib + fulvastrant + chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy.
Detailed description
This is a prospective, single center, single arm phase II study. In the safety lead-in stage, 6 subjects will be recruited and administered with surufatinib 250 mg/d, QD PO; Fulvestrant 500mg, im, Q4W; Chidamide 30mg, PO, BIW, with four weeks as a cycle. DLTs of the 6 subjects will be evaluated in the first cycle to determine the recommended dosage of combinational therapy. Then 57 subjects will be recruited and administered with the triplet regimen to explore the efficacy and safety of combinational treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: surufatinib + fulvestrant + chidamidesurufatinib + fulvestrant + chidamide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed the Informed Consent Form;
- 18-75 Years (concluding 18 and 75 Years), female;
- Pathologically and cytologically confirmed non-resectable stage IV Her2 negative, HR positive (ER+ and / or PR+) breast cancer;
- Relapsed or progressed after at least first-line endocrine therapy, with patients of primary endocrine resistance excluded (patients of recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy are eligible; patients progressed more than 1 year but less than 2 years after adjuvant endocrine therapy are not eligible);
- 2 weeks or more from the last endocrine therapy and 3 weeks or more from the last chemotherapy before enrollment;
Key exclusion criteria (16 listed)
- Previous treatment with VEGFR inhibitor, HDAC inhibitor or fulvestrant;
- Organ surgery performed 6 weeks before enrollment;
- A history of other malignancies within 5 years prior to enrollment, except for cervical carcinoma in situ, basal or squamous cell skin cancer;
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg;
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 |
|---|---|---|
| surufatinib + fulvestrant + chidamidesurufatinib: 250 mg/d, QD PO; Fulvestrant: 500mg, im, Q4W; Chidamide 30mg, PO, BIW; Q4W | Drug | Experimental |
Primary outcome
PFS
Time frame: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
4 secondary outcomes
ORR
Time frame: up to 3 years
DCR
Time frame: up to 3 years
OS
Time frame: up to 3 years
Adverse Events (AEs)
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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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. This study is not recruiting at the moment.
5 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 surufatinib + fulvestrant + chidamide in people with Breast Cancer and Breast Cancer Female, run by The First Affiliated Hospital of Zhengzhou University at 5 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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Zong, M.D. (+ 86 13523586882, 1157506518@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 3 years). 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 2 Sep 2022.