Combination treatment for HR+/HER2- breast cancer

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

This study is testing a new combination of treatments to see if it can help shrink tumors in postmenopausal women with certain types of breast cancer before they have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Harbin Medical University (Academic / other)
• Drugs / interventions: radiation, Adebrelimab
• Locations: 2 sites (Harbin, Heilongjiang and 1 other locations)
• Trial ID: NCT06599216 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Adebrelimab, a PD-L1 inhibitor, combined with Dalpiciclib, a CDK4/6 inhibitor, along with standard endocrine therapy as a neoadjuvant treatment for stages II-III hormone receptor-positive (HR+), HER2-negative breast cancer. It is a single-center, open-label, single-arm study focusing on postmenopausal women with confirmed HR+/HER2- invasive breast cancer. The trial aims to determine how well this combination therapy works in shrinking tumors before surgery.

Who should consider this trial

Good fit: Ideal candidates include postmenopausal women aged 18 and older with histologically confirmed HR+/HER2- invasive breast cancer at stages II-III.

Not a fit: Patients with HER2-positive breast cancer or those who are not postmenopausal may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with HR+/HER2- breast cancer by enhancing tumor response to therapy.

How similar studies have performed: Other studies have shown promising results with similar combinations of PD-L1 inhibitors and CDK4/6 inhibitors in breast cancer treatment, indicating potential for success.

Eligibility criteria

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 \&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);
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\&#39;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\&#39;s participation in this study by the investigator.

Where this trial is running

Harbin, Heilongjiang and 1 other locations

• Harbin Medical Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jinsong Wang

Conditions Breast Cancer; HR+/HER2- Breast Cancer