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

NCT06599216 | Active Not Recruiting Phase 2

• 1 other identifier: MA-BC-II-071
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer; HR+/HER2- Breast Cancer

Outcome Measures

Primary Outcomes (1)

• tpCR rate

  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 Outcomes (4)

• OS

  up to 3 years

• EFS

  up to 3 years

• Ki67

  Baseline and At Surgery

• ORR

  Baseline up to Cycle 5（each cycle is 28 days）

Study Arms (1)

Treatment Group

EXPERIMENTAL

Drug: Adebrelimab+Dalpciclib+Standard Endocrine Therapy

Interventions

Adebrelimab+Dalpciclib+Standard Endocrine Therapy DRUG

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

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Postmenopausal women, aged ≥18 years;
• 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;
• Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER \&gt;10% tumor cell positive is defined as ER positive, PR \&gt;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);
• Histologically confirmed invasive breast cancer, stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) ;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• According to the RECIST 1.1 standard, at least one measurable lesion exists;
• 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);
• Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

You may not qualify if:

• Previous use of CDK4/6 inhibitors or PD1/PD-L1 monoclonal antibody or concurrent treatment with any other antitumor therapy;
• Severe organ dysfunction;
• Inability to swallow,chronic diarrhea and intestinal obstruction,there are multiple factors that affect drug intake and absorption;
• Patients with known HBV or HCV infection active phase or HBV DNA≥500, or chronic phase with abnormal liver function;
• 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)
• 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;
• 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;
• Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period;
• According to the discretion of the investigator, there are significant risks to patient safety or concomitant diseases affecting the patient\&#39;s completion of the study (including but not limited to severe hypertension, severe diabetes, active infection);
• Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia;
• Any condition deemed inappropriate for the patient\&#39;s participation in this study by the investigator.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (2)

Harbin Medical Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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 of Treatment

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (2)