Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor

NCT06556862 | Not Yet Recruiting Phase 2

• 1 other identifier: OBU-BC-II-211
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HR+/HER2- Advanced Breast Cancer

Keywords

post-CDK4/6 inhibitor; Dalpiciclib; HADCi; HR+/HER2- advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first

  1 Year

Secondary Outcomes (6)

• ORR

  2 months

• CBR

  2 Years

• DCR

  2 Years

• DoR

  2 Years

• OS

  2 Years

Study Arms (1)

Dalpiciclib + plus HDACi

EXPERIMENTAL

Dalpiciclib + plus HDACi + Endocrine therapy (doctor's choice)

Drug: Dalpiciclib; Drug: Chidamide; Drug: Enitinostat

Interventions

Dalpiciclib DRUG

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).

Also known as: SHR6390

Dalpiciclib + plus HDACi

Chidamide DRUG

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

Dalpiciclib + plus HDACi

Enitinostat DRUG

5mg/QW，po.

Dalpiciclib + plus HDACi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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%;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Interventions

dalpiciclib; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Study Officials

• Tao Wang

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinmei Zhou, Doctor

CONTACT

+86-010-66947250; jinzhu2714@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 16, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)