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HR+/HER2- Advanced Breast CancerPhase 1NCT05586841

Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study

A Phase 1 study testing Dalpiciclib and Chidamide in people with HR+/HER2- Advanced Breast Cancer, run by Beijing 302 Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase 1B study to explore the maximum tolerated dose (MTD) of dalpiciclib + chidamide 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 and Chidamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
1 Oct 2022to 30 Mar 2026
Phase
Phase 1
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 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
  • Faged ≥ 18 years.
  • ECOG PS score: 0-2 points.
  • Expected survival ≥ 3 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.

China1 site

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

Other trials in China

About this study

A phase 1B study to explore the maximum tolerated dose (MTD) of dalpiciclib + chidamide in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy

Being tested
Dalpiciclib, Chidamide
Keywords
Dalpiciclib, Chidamide, Maximum Tolerated Dose, the failure of CDK4/6 inhibitor therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalpiciclibDrug

    Also called SHR6390

    Dalpiciclib: 100 mg/d or 125 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

    Chidamide: 25 mg/BIW or 20 mg/BIW, po., q2w. 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

Study groups in NCT05586841
Study groupRoleWhat they receive
Dalpiciclib + ChidamideExperimentalDalpiciclib will be administered in a dose of 100 mg/d or 125 mg/d. Chidamide shall be designed in a dose of 25 mg/BIW or 20 mg/BIW
Receives: Drug: Dalpiciclib; Drug: Chidamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of Dalpiciclib + Chidamide

    Bayesian optimal interval (BOIN) design method will be used in this clinical trial to determine the maximum tolerated dose (MTD).

    Measured: 2 Years

Secondary outcomes (3)

  1. Objective response rate (ORR) of different dose groups

    According to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients.

    Measured: 2 Years

  2. Safety of different dose groups (incidence of treatment-related adverse events)

    The severity of adverse events shall be determined according to CTCAE v5.0. During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, duration, measures taken and outcome of adverse events.

    Measured: AE recorded from infromed consent to 28 days after treatment completion

  3. PFS

    The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Dec 2025
  4. Study completion30 Mar 2026

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586841
Sponsor's protocol ID
MA-BC-II-047
Status last verified
Aug 2024
First submitted
17 Oct 2022
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou J, Wu X, Du Y, Xiao J, Kang X, Chen J, Wang X, Tai Y, Bian L, Zhang S, Pang Z, Li Y, Jiang Z, Xu X, Wang T. Dalpiciclib plus chidamide in HR + /HER2-advanced breast cancer after CDK4/6 inhibitor failure: a phase Ib trial. Nat Commun. 2026 Mar 20;17(1):5177. doi: 10.1038/s41467-026-70650-6.

    PubMed 41862468

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dalpiciclib and Chidamide 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: finished, as of the sponsor's last update on 29 May 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Tolerated Dose (MTD) of Dalpiciclib + Chidamide (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586841, which also lists 1 linked publication.

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 29 May 2026.

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