Breast CancerPhase 2NCT06547476
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed
A Phase 2 study testing Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib in people with Breast Cancer, run by Guangdong Provincial People's Hospital.
Trial summary
This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer. Participants must have HER2-low and PD-L1 positive （CPS≥1）breast cancer that has been treated before. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Dec 2026
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has pathologically documented breast cancer that:
- Is unresectable or metastatic
- Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
- Is HR-positive
- Has progressed on, and would no longer benefit from, endocrine therapy
- Has been treated with 0 to 1 prior lines of chemotherapy in the recurrent or metastatic setting
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- Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
- PD-L1 positive （CPS≥1）
- Has documented radiologic progression (during or after most recent treatment)
- Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
- assessment of HER2 status
- assessment of post-treatment status
- Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
- Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
- Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Who cannot join
- Allergies to any monoclonal antibody or tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
- Previously received histone deacetylase inhibitors,or immune checkpoint inhibitor, or angiogenesis inhibitors.
- Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- Known active CNS metastases and/or carcinomatous meningitis.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
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- Pregnant or lactating female.
- Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
- Participate in other clinical trials currently or within 4 weeks prior to enrollment.
About this study
Official title: A Phase 2, Single Arm Study Investigating the Use of Chidamide and PD-1 Antibody Combination With Anlotinib in HER2-low, Unresectable and/or Metastatic Breast Cancer
This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer.
Participants must have HER2-low and PD-L1 positive （CPS≥1）breast cancer that has been treated before.
Participants' cancer:
Cannot be removed by an operation Has spread to other parts of the body
- Conditions
- Breast Cancer
- Being tested
- Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinibDrug
Tucidinostat (chidamide)，30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), Anlotinib | Experimental | Not described Receives: Drug: Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Time from treatment until disease progression or death
Measured: 2 years
Secondary outcomes (4)
Objective Response Rate（ORR）
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Measured: 2 years
Clinical Benefit Rate (CBR)
the total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months
Measured: 2 years
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）
Measured: 2 years
Overall survival (OS)
Time from treatment until 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 posted9 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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 Guangdong Provincial People's HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547476
- Sponsor's protocol ID
- CSIIT-C56
- Status last verified
- Jul 2024
- First submitted
- 7 Aug 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single Arm Study Investigating the Use of Chidamide and PD-1 Antibody Combination With Anlotinib in HER2-low, Unresectable and/or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06547476
- Acronym / sponsor ID
- CSIIT-C56
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (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 Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer.
Participants must have HER2-low and PD-L1 positive （CPS≥1）breast cancer that has been treated before.
Participants' cancer:
Cannot be removed by an operation Has spread to other parts of the body
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), Anlotinib | Experimental | Drug: Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Has pathologically documented breast cancer that:
- Has documented radiologic progression (during or after most recent treatment)
- Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
- Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
- Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Key exclusion criteria (9 listed)
- Allergies to any monoclonal antibody or tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
- Previously received histone deacetylase inhibitors,or immune checkpoint inhibitor, or angiogenesis inhibitors.
- Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- Known active CNS metastases and/or carcinomatous meningitis.
- Received a live vaccine within 4 weeks of the first dose of study medication.
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 |
|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinibTucidinostat (chidamide)，30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w | Drug | Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), Anlotinib |
Primary outcome
Progression-free survival(PFS)
Time frame: 2 years
Time from treatment until disease progression or death
4 secondary outcomes
Objective Response Rate（ORR）
Time frame: 2 years
Clinical Benefit Rate (CBR)
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
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 9 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib in people with Breast Cancer, run by Guangdong Provincial People's Hospital.
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 15 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 2 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 9 Aug 2024.