Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR + / HER2- Breast Cancer

August 19, 2025 updated by: Jinsong Wang, Harbin Medical University

Adebrelimab Combined With Dalpicicliband Standard Endocrine Therapy for HR + / HER 2-breast Cancer:A Single-center,Open-label,Single-arm Clinical Trial

This study intends to explore the efficacy and safety of PD-L1 inhibitor Adebrelimab combined with the CDK4/6 inhibitor Dalpcicilib and standard endocrine therapy given as neoadjuvant treatment in stages II-III hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center, open-label, single-arm clinical trial aims to evaluate the efficacy and safety of the neoadjuvant treatment with the PD-L1 inhibitor Adebrelimab in combination with the CDK4/6 inhibitor Dalpicicilib in combination with standard endocrine therapy, for stages II-III hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Postmenopausal women, aged ≥18 years;

  2. Postmenopausal patients and all patients in the screening period must one of the following:

    • Previous bilateral oophorectomy, or aged ≥60 years;
    • Aged <60 years, natural Postmenopausal status (defined as spontaneous cessation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at the postmenopausal level;
  3. Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER >10% tumor cell positive is defined as ER positive, PR >10% tumor cell positive is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);
  4. Histologically confirmed invasive breast cancer, stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) ;
  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  6. According to the RECIST 1.1 standard, at least one measurable lesion exists;

  7. The main organs have basically normal functions and meet the following conditions:

    • Bone marrow function: Hb≥90 g/L (no blood was transfused within 14 days); ANC≥1.5×109/L;PLT≥80×I09/L;
    • Liver and kidney function: TBlL≤1.5×ULN; ALT and AST≤3×ULN; serum Cr≤1.5 ULN and creatinine clearance>50 ml/min (Cockcroft-Gault formula);
  8. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

  1. Previous use of CDK4/6 inhibitors or PD1/PD-L1 monoclonal antibody or concurrent treatment with any other antitumor therapy;
  2. Severe organ dysfunction;
  3. Inability to swallow,chronic diarrhea and intestinal obstruction,there are multiple factors that affect drug intake and absorption;
  4. Patients with known HBV or HCV infection active phase or HBV DNA≥500, or chronic phase with abnormal liver function;
  5. History of active autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
  6. History of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia;
  7. History of any heart disease, including:1)medicated or clinically significant arrhythmia; 2) myocardial infarction; 3) heart failure; 4) any other cardiac disease judged by the investigator for the trial;
  8. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period;
  9. According to the discretion of the investigator, there are significant risks to patient safety or concomitant diseases affecting the patient's completion of the study (including but not limited to severe hypertension, severe diabetes, active infection);
  10. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia;
  11. Any condition deemed inappropriate for the patient's participation in this study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Drug: Adebrelimab+Dalpciclib+Standard Endocrine Therapy
Adebrelimab: 1200mg, intravenously, Q4w Dalpiciclib: 150mg once a day for 3 weeks, stop for 1 week, Q4w Standard Endocrine Therapy: Choice of endocrine therapy is according to guidelines and centre policy by investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tpCR rate
Time Frame: through study completion, an average of one and a half years
Total pathologic complete response (tpCR) rate, defined as ypT0/is, ypN0 as assessed by investigator.
through study completion, an average of one and a half years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: up to 3 years
OS is defined as the time between enrollment and the patient's death due to any cause.
up to 3 years
EFS
Time Frame: up to 3 years
Event-Free Survival (EFS) is defined as the time from firest dose to disease progression, disease recurrence, or death, whichever comes first.
up to 3 years
Ki67
Time Frame: Baseline and At Surgery
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Baseline and At Surgery
ORR
Time Frame: Baseline up to Cycle 5（each cycle is 28 days）
Objective response rate(ORR) is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.
Baseline up to Cycle 5（each cycle is 28 days）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-BC-II-071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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