HR+/HER2- Advanced Breast CancerPhase 2NCT06556862
Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor
A Phase 2 study testing Dalpiciclib, Chidamide and Enitinostat in people with HR+/HER2- Advanced Breast Cancer, run by Beijing 302 Hospital at 1 site in China.
Trial summary
A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+/HER2- Advanced Breast Cancer
- What is being tested?
- Dalpiciclib, Chidamide and Enitinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study and sign the informed consent form
- aged ≥ 18 years.
- ECOG PS score: 0-2 points.
- Expected survival ≥ 6 months.
- Regionally recurrent or metastatic disease with histologically or cytologically confirmed ER+ and/or PR+ (≥ 10%), HER2- breast cancer that is not suitable for definitive excision or radiation therapy.
- Previously received antitumor therapy: 1) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; 2) Disease recurrence and/or metastasis during or after treatment with Palbociclib or Abemaciclib or Ribociclib in the setting of (neo-)adjuvant therapy, or during treatment with palbociclib or Abemaciclib or Ribociclib in a metastatic setting or after disease progression; 3) No more than 3 lines of endocrine therapy have been previously received for recurrent or metastatic breast cancer. 4) Line number of previous chemotherapy ≤1 line
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- At least one extracranial measurable lesion as defined by RECIST v1.1;
- The function of vital organs meets the requirements;
- Absolute neutrophil count ≥ 1.5 × 10^9/L;
- Platelets ≥ 90 × 10^9/L;
- Hemoglobin ≥ 90g/L;
- Total bilirubin (TBIL) ≤ 1.5 × ULN;
- ALT and AST ≤ 2.5 × ULN;
- Urea/blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- The QT correction by the Fridericia formula (QTcF) is < 470 ms. INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.
- Subject recovers from any AE related to previous antitumor therapy before the first administration of the study drug (Grade ≤ 1)
Who cannot join
- Previously received treatment with histone deacetylase inhibitor (HDACi);
- Previously received Dalpiciclib;
- MRI or lumbar puncture confirmed leptomeningeal metastasis;
- Central nervous system metastasis is confirmed by imaging; The following conditions will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain metastases, stable for at least 4 weeks, and no symptomatic treatment (including glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical symptoms;
- The participants presented with visceral crisis (such as lymphangitis carcinomatosis, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver function), rapid disease progression, and that is not suitable for endocrine therapy;
- Participants had ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, which required drainage within 4 weeks before the first medication;
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- Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;
- Subjects that are diagnosed with any other malignancy within 5 years prior to the study, excluding non-melanoma skin cancer treated with radical therapy, basal or squamous cell skin cancer or carcinoma in situ of the cervix and papillary thyroid.
- The subject has undergone major surgery or major trauma or is expected to undergo major surgery within 4 weeks before the start of treatment;
- A known history of allergy to the drug ingredient of this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
About this study
Official title: Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study
A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.
- Conditions
- HR+/HER2- Advanced Breast Cancer
- Being tested
- Dalpiciclib, Chidamide, Enitinostat
- Keywords
- post-CDK4/6 inhibitor, Dalpiciclib, HADCi, HR+/HER2- advanced breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Also called SHR6390
100 mg/d, po., qd, administered on an empty stomach (fasting should be ensured at least 1 hour before and 1 hour after administration). The drug will be administered in a 28-day cycle, with continuously administration in the first 3 weeks (D1-21), and discontinuation in the fourth week (D22-28).
ChidamideDrug
25 mg/BIW, po. The interval between doses should not be less than 3 days (e.g. Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), administered 30 minutes after meals
EnitinostatDrug
5mg/QW，po.
| Study group | Role | What they receive |
|---|---|---|
| Dalpiciclib + plus HDACi | Experimental | Dalpiciclib + plus HDACi + Endocrine therapy (doctor's choice) Receives: Drug: Dalpiciclib; Drug: Chidamide; Drug: Enitinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first
Measured: 1 Year
Secondary outcomes (6)
ORR
Objective response rate
Measured: 2 months
CBR
Clinical benefit rate: CR+PR+SD≥6 months
Measured: 2 Years
DCR
Disease Control Rate: CR+PR+SD
Measured: 2 Years
DoR
The time from the beginning of CR or PR to the time when the tumor was first evaluated as PD or any cause of death.
Measured: 2 Years
OS
The time from the beginning of treatment to the time of death caused by any cause
Measured: 2 Years
Safety
Adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE), in accordance with the NCI-CTC AE version 5.0 criteria. AE recorded from infromed consent to 28 days after treatment completion.
Measured: AE recorded from infromed consent to 28 days after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Tao, Beijing 302 Hospital
- Investigators
- Tao Wang, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556862
- Sponsor's protocol ID
- OBU-BC-II-211
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study
- ClinicalTrials.gov ID
- NCT06556862
- Acronym / sponsor ID
- OBU-BC-II-211
- Conditions
- HR+/HER2- Advanced Breast Cancer
- Keywords
- post-CDK4/6 inhibitor, Dalpiciclib, HADCi, HR+/HER2- advanced breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 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.
A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalpiciclib + plus HDACi | Experimental | Drug: Dalpiciclib, Drug: Chidamide, Drug: EnitinostatDalpiciclib + plus HDACi + Endocrine therapy (doctor's choice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects voluntarily participate in this study and sign the informed consent form
- aged ≥ 18 years.
- ECOG PS score: 0-2 points.
- Expected survival ≥ 6 months.
- Regionally recurrent or metastatic disease with histologically or cytologically confirmed ER+ and/or PR+ (≥ 10%), HER2- breast cancer that is not suitable for definitive excision or radiation therapy.
Key exclusion criteria (10 listed)
- Previously received treatment with histone deacetylase inhibitor (HDACi);
- Previously received Dalpiciclib;
- MRI or lumbar puncture confirmed leptomeningeal metastasis;
- Central nervous system metastasis is confirmed by imaging; The following conditions will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain metastases, stable for at least 4 weeks, and no symptomatic treatment (including glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical symptoms;
- The participants presented with visceral crisis (such as lymphangitis carcinomatosis, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver function), rapid disease progression, and that is not suitable for endocrine therapy;
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 |
|---|---|---|
| DalpiciclibAlso: SHR6390100 mg/d, po., qd, administered on an empty stomach (fasting should be ensured at least 1 hour before and 1 hour after administration). The drug will be administered in a 28-day cycle, with continuously administration in the first 3 weeks (D1-21), and discontinuation in the fourth week (D22-28). | Drug | Dalpiciclib + plus HDACi |
| Chidamide25 mg/BIW, po. The interval between doses should not be less than 3 days (e.g. Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), administered 30 minutes after meals | Drug | Dalpiciclib + plus HDACi |
| Enitinostat5mg/QW，po. | Drug | Dalpiciclib + plus HDACi |
Primary outcome
PFS
Time frame: 1 Year
Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first
6 secondary outcomes
ORR
Time frame: 2 months
CBR
Time frame: 2 Years
DCR
Time frame: 2 Years
DoR
Time frame: 2 Years
OS
Time frame: 2 Years
Safety
Time frame: AE recorded from infromed consent to 28 days after treatment completion
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 13 Aug 2025.
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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.
Tao Wang principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalpiciclib, Chidamide and Enitinostat in people with HR+/HER2- Advanced Breast Cancer, run by Beijing 302 Hospital at 1 site 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 17 inclusion and 10 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jinmei Zhou, Doctor (+86-010-66947250, jinzhu2714@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 Year). 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 13 Aug 2025.