HR Positive HER2 Negative Advanced Breast CancerPhase 1/2NCT05335473
Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure
A Phase 1/2 study testing Eribulin and Tucidinostat in people with HR Positive HER2 Negative Advanced Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR Positive HER2 Negative Advanced Breast Cancer
- What is being tested?
- Eribulin and Tucidinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2022to 1 Sep 2026
- Phase
- Phase 1/2
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
- -
- Subjects must meet all of the following criteria to be enrolled:
- 1. Age ≥18 years and ≤75 years at the time of signing the informed consent; 2. The physical status score of the Eastern Oncology Consortium (ECOG) was ≤2 points; 3. Confirmed by pathology as HR+/HER2- (according to American College of Clinical Oncology/American College of Pathologists guidelines) (Note: HER2 feminine is defined as ①IH0; IHC1+; Locally advanced or metastatic IHC2+ : FISH-) Sexual female breast cancer patients, not suitable for radical treatment of the purpose of surgery or radiotherapy; 4. Proving that endocrine therapy is difficult to treat or resistant to endocrine therapy; 5. Used 1-2 chemotherapy regiments in the advanced stage; 6. Received at least one taxane and CDK4/6 inhibitor (including unmarketed ones) at any stage; 7. If a patient in the early stage relapses within 12 months of adjuvant chemotherapy (new), it can be counted as one advanced chemotherapy line Number; 8. The total number of treatment lines in the late stage ≤3 lines; 9. At least 1 measurable lesion was present according to RECIST1.1; External radiation therapy (EBRT) or local area treatment (such as radiofrequency ablation) of the lesion must show evidence of disease progression (according to RECIST 1.1), can be used as target lesion; 10. Life expectancy ≥3 months; 11. The functional level of the organ must meet the following requirements:
- Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days); PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used); Hb≥100 g/L(no corrective treatment was used within 7 days);
- Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤3 x ULN; Glutamine transpeptidase GGT≤2.5×ULN; If liver metastasis exists, ALT and/or AST≤5×ULN; Glutamine transpeptidase GGT≤5×ULN; Urea, urea nitrogen (BUN), creatinine (Cr) ≤1.5×ULN;
- Cardiac color ultrasound: LVEF≥50%;
Show all 9Show fewer
- 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms, female<470 ms.
- 11. The time interval between the end of the last antitumor therapy and the first administration of the study drug meets the following requirements: surgery The interval must be ≥4 weeks (minor surgery, such as tumor biopsy, thoracopuncture, or intravenous catheter placement, is not limited); Recovery of adverse reactions to previous antitumor therapy (radiotherapy, chemotherapy, targeting) to ≤ Grade 1 (phase Ib required patients A washout period of 7-14 days after natural recovery without symptomatic drugs or symptomatic treatment).
- 12. Voluntarily agrees to and signs a written informed consent and is willing and able to comply with all aspects of the test protocol,The patient may withdraw consent at any time without prejudice to his rights and interests.
Who cannot join
- -
- Subjects will not be enrolled if they meet any of the following criteria:
- Receiving neoadjuvant or adjuvant therapy containing Iribulin within one year prior to treatment initiation;
- Patients with recurrent or metastatic breast cancer who have failed or responded to previous treatment with Iribulin (achieved CR/PR/SD), but tumor progression within 6 months after cessation of aribulin therapy;
- Patients who have received any HDAC inhibitor at any time in the past;
- Participated in clinical trials of unmarketed drugs within 4 weeks before enrollment;
Show all 17Show fewer
- Exclude subjects with brain or subdural metastases. Unless the patient has completed local treatment and is stable on imaging Those who had maintained the condition for at least 4 weeks, had stopped systemic sex hormone therapy and had stable symptoms for at least 4 weeks were included(By comparing head enhancement CT or MRI performed during screening with head enhancement performed at least 4 weeks earlier CT or MRI to determine the stability of the lesion);
- Before screening, the toxicity of the original treatment regimen had not recovered, and there were still more than grade 1 toxic reactions (CTCAE5.0);
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow,Chronic diarrhea, intestinal obstruction, etc);
- Severe/uncontrolled disease or active infection;
- Severe cardiovascular injury (greater than NYHA Class II congestive heart failure) History), unstable angina pectoris or myocardial infarction within the past 6 months, or severe arrhythmia;
- Subjects with allograft requiring immunosuppressive therapy.
- Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal); Known human immunodeficiency disease Hiv-positive subjects.
- Had other malignancies within the previous 5 years, excluding cured papillary thyroid carcinoma and in situ cervix Carcinoma, skin basal cell carcinoma or skin squamous cell carcinoma;
- Subjects with hypersensitivity to softin B and/or softin B chemical derivatives.
- Pregnant and lactating women, fertile women who have tested positive for baseline pregnancy tests,or were unwilling to use effective contraception throughout the trial period and within 90 days after the last administration of the study drug age patients;
- The investigator considers the subject unfit for any medical condition to enter the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I b/ II Clinical Study of Iribrine Mesylate Plus Tucidinostat in the Treatment of HR+/HER2- Locally Relapsed or Metastatic Breast Cancer After Previous CDK4/6 Inhibitor Failure
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
Read the detailed description
To explore the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of the regimen of Eribulin plus Tucidinostat , and to initially explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
- Being tested
- Eribulin and Tucidinostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin and TucidinostatDrug
phase 1b： 3+3 trial design will be used for Tucidinostat dose escalation cohorts phase 2: Eribulin+Tucidinostat
| Study group | Role | What they receive |
|---|---|---|
| Eribulin plus Tucidinostat | Experimental | phase 1b： 3+3 trial design will be used for Tucidinostat dose escalation cohorts phase 2: Eribulin+Tucidinostat Receives: Drug: Eribulin and Tucidinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT for phaseⅠb
Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any > Grade 3 non-hematologic toxicity.
Measured: 1 year
Progression-Free Survival (PFS) for phase Ⅱ
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Measured: 2 years
MTD for phaseⅠb
Maximum tolerated dose is highest dose level in which 6 patients treated with at most 1 experiencing DLT.
Measured: 1 year
Secondary outcomes (6)
Progression-Free Survival (PFS) for phaseⅠb
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Measured: 2 years
adverse events (AE)
The level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0).
Measured: 2 years
Objective Response Rate (ORR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Measured: 2 years
Clinical Benefit Rate (CBR)
CBR is defined as the rate of patients who achieved complete response, partial response, and stable disease for >= 24 weeks as the best response of treatment.
Measured: 2 years
Duration of Response (DOR)
DOR is defined as the time from the date of the first response (≥PR) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever happens first
Measured: 2 years
Overall Survival (OS)
OS defined as the time from the first study treatment administration to death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start13 May 2022
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Why it stopped: The anticipated efficacy was not achieved; the primary objective of Stage 1 in the Simon-2 design was not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR Positive HER2 Negative Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
- Investigators
- Min Yan, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335473
- Sponsor's protocol ID
- HNCH-MBC07
- Other IDs
- CSIIT-C28
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No