Adding CDK4/6 inhibitors to neoadjuvant endocrine therapy for breast cancer

Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy in High Risk Early HR+/HER2-breast Cancer Based on Molecular Marker

This study is testing if adding a new type of medication to standard hormone therapy can help women with high-risk early breast cancer do better before surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05809024 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to identify the appropriate population for adding CDK4/6 inhibitors to neoadjuvant endocrine therapy in patients with high-risk early hormone receptor-positive, HER2-negative breast cancer. The study will involve newly treated female patients aged 18 to 75 with specific tumor characteristics and hormone receptor status. Participants will receive letrozole as part of their treatment regimen, and their eligibility will be determined based on various clinical and laboratory criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are newly diagnosed female patients aged 18 to 75 with locally advanced hormone receptor-positive, HER2-negative breast cancer.

Not a fit: Patients with non-invasive breast cancer or those with HER2-positive tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk breast cancer by personalizing therapy based on molecular detection.

How similar studies have performed: Other studies have shown promising results with CDK4/6 inhibitors in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Newly treated female patients, ≥18 and ≤75 years;
2. ECOG score 0-1;
3. Breast cancer following:

   Histologically confirmed invasive breast cancer with primary tumor diameter \>2 cm by standard evaluation methods.Tumor stage: cT2-cT4/cN0-cN3/cM0 (clinical phase II and III)
4. HR+/HER2- breast cancer confirmed by pathological examination, defined as: primary HR+/HER2- breast cancer performed by the pathology department of the Central Hospital;
5. Get hormone receptor status (ER and PR);
6. Major organ function following:

   Complete blood count: Neutrophil (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥ 90×109/L; hemoglobin (Hb) ≥90 g/L; Blood Biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) ≤ 1.5×ULN; Aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Urea nitrogen (BUN) ≤ 1.5×ULN; Creatinine (Cr) ≤ 1.5×ULN; Twelve-lead electrocardiogram: Fridericia corrected QT Interval (QTcF) woman \< 470 ms (QTcF=QT/(RR\^1/3));
7. Woman who are not menopausal or have not been surgically sterilized agree to abstain from sex or use effective contraceptive methods for at least the duration of the study treatment and for 7 months after the last dosing;
8. Volunteer to participate in the study, sign informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion Criteria:

1. IV stage breast cancer or metastatic breast cancer;
2. Inflammatory breast cancer;
3. Any previous malignant tumor or previous anti-tumor therapy or radiotherapy were not allowed, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
4. Participate in other clinical trials;
5. Patients were not allowed who had undergone major non-breast cancer related surgery within 4 weeks prior to randomization or had not fully recovered from such surgery;
6. Patients were not allowed who had received blood transfusion or colony stimulating factor treatment within 2 weeks before randomization;
7. Patients were not allowed who allergic to drug components;
8. Patients were not allowed who had a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
9. Patients have heart disease were not allowed including: (1) angina pectoris; (2) medically treatable or clinically significant arrhythmias; (3) myocardial infarction; (4) heart failure; (5) any other heart disease that the investigator has determined is not suitable for participation in the study;
10. Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or fertile women who were unwilling to take effective contraceptive measures during the test period were not allowed;
11. Patients have concomitant diseases that endanger patient safety or influence the completion of the study were not allowed (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.);
12. Patients were not allowed who with inability to swallow, chronic diarrhea and intestinal obstruction, accompany multiple factors affecting the administration and absorption of medicines;
13. Any other circumstances in which the investigator considers the patients unsuitable for participation in the study.

Where this trial is running

Jinan, Shandong

• Breast Cancer Center, Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: yongsheng wang — Shandong Cancer Hospital and Institute
• Study coordinator: yongsheng wang, MD

Conditions Locally Advanced Breast Cancer; Hormone Receptor Positive，HER2-negative Breast Cancer