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

NCT ID: NCT06556862

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dalpiciclib + plus HDACi

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

Group Type: EXPERIMENTAL

Dalpiciclib

Intervention Type: 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).

Chidamide

Intervention Type: 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

Enitinostat

Intervention Type: DRUG

5mg/QW，po.

Interventions

Dalpiciclib

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).

Intervention Type: DRUG

Chidamide

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

Intervention Type: DRUG

Enitinostat

5mg/QW，po.

Intervention Type: DRUG

Other Intervention Names

SHR6390

Eligibility Criteria

Inclusion Criteria

1. Subjects voluntarily participate in this study and sign the informed consent form

2. aged ≥ 18 years.

3. ECOG PS score: 0-2 points.

4. Expected survival ≥ 6 months.

5. 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.

6. 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

7. At least one extracranial measurable lesion as defined by RECIST v1.1;

8. 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.

9. Subject recovers from any AE related to previous antitumor therapy before the first administration of the study drug (Grade ≤ 1)

Exclusion Criteria

1. Previously received treatment with histone deacetylase inhibitor (HDACi);

2. Previously received Dalpiciclib;

3. MRI or lumbar puncture confirmed leptomeningeal metastasis;

4. 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;

5. 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;

6. Participants had ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, which required drainage within 4 weeks before the first medication;

7. Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;

8. 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.

9. The subject has undergone major surgery or major trauma or is expected to undergo major surgery within 4 weeks before the start of treatment;

10. A known history of allergy to the drug ingredient of this protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Tao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tao Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jinmei Zhou, Doctor

Role: CONTACT

jinzhu2714@sina.com

+86-010-66947250

Other Identifiers

OBU-BC-II-211

Identifier Type: -

Identifier Source: org_study_id