Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）

Trial Title: Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）

NCT ID: NCT06107673

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Docetaxel
Epirubicin
Aromatase Inhibitors

Conditions: Keywords:
HER2- ER+
Neoadjuvant therapy
Dalpiciclib

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Dalpiciclib
Description: Dalpiciclib: Take 125 mg once daily for 3 weeks, then stop for 1 week. Each cycle is completed in 4 weeks. It is recommended to take the medication approximately at the same time each day, with warm water, preferably on an empty stomach. Fasting for at least 1 hour before and after medication is advised.
Arm group label: neoadjuvant endocrine group

Other name: SHR6390

Intervention type: Drug
Intervention name: Aromatase inhibitor
Description: AI: Take according to the instructions provided.
Arm group label: neoadjuvant endocrine group

Other name: AI

Intervention type: Drug
Intervention name: Docetaxel injection
Description: Administered as a 75 mg/m2 intravenous infusion over approximately 30 minutes. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.
Arm group label: neoadjuvant chemotherapy group

Intervention type: Drug
Intervention name: Epirubicin Hydrochloride Injection
Description: Administered as a 75 mg/m2 intravenous infusion. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.
Arm group label: neoadjuvant chemotherapy group

Intervention type: Drug
Intervention name: Cyclophosphamide injection
Description: Administered as a 500 mg/m2 intravenous infusion. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.
Arm group label: neoadjuvant chemotherapy group

Summary: This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive（ER≥50%），HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.

Detailed description: This study is a multi-center, randomized, prospective non-inferiority exploratory phase II clinical trial. Eligible subjects were randomly assigned in a 1:1 ratio to either the dalpiciclib combined with AI group （neoadjuvant endocrine group） or the AC-T group （chemotherapy group） after screening. The administration of the investigational drugs started within 48 hours after randomization. Subjects will receive either 24 weeks of dalpiciclib combined with AI or AC-T treatment until disease progression, intolerable adverse events, withdrawal of informed consent, or discontinuation by the investigator's judgment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Sign the informed consent form to participate in the clinical research. 2. Confirmed postmenopausal females diagnosed with invasive breast cancer. 3. Clinical stage T1-3N1M0. 4. Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++) but in situ hybridization (ISH) indicates negative. Strong positive for ER: ER immunohistochemistry test shows 50% or more tumor cells positive. 5. No prior breast cancer-related treatment. 6. No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I). 7. ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction. 8. Within 1 week prior to enrollment, routine blood tests are essentially normal: Absolute neutrophil count (NEUT#) ≥ 1.5×10^9 /L; White blood cell count (WBC) ≥ 3.0×10^9 /L; Platelets ≥ 90×10^9 /L; Hemoglobin ≥ 90 g/L. 9. Within 1 week prior to enrollment, liver and kidney function tests are essentially normal: Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN); Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤ 2× ULN; Serum creatinine ≤ 1.5× ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min. 10. For women of childbearing age, negative serum or urine pregnancy test results before participation; premenopausal women during the study period should use medically acceptable methods of contraception. 11. Exhibits good compliance. Exclusion Criteria: 1. Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test at baseline and do not agree to use effective contraception during the study. 2. Patients with a known history of severe allergic reactions to any investigational drug components (NCI-CTCAE Grade > 3) or with any clearly documented drug allergy. 3. Patients with bilateral breast cancer or inflammatory breast cancer. 4. Patients with metastatic (stage IV) breast cancer at initial diagnosis. 5. Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction. 6. Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc. 7. Current diagnosis of severe liver-related diseases such as acute hepatitis, fulminant hepatitis, coagulation factor synthesis disorders. If HBV surface antigen or HBV core antibody are positive, the peripheral blood HBV DNA titer should be < 1×10^3 IU/ml for eligibility. 8. Any other serious medical condition or comorbidity that may interfere with participation in the study or may significantly affect the safety of the subject (e.g., active or uncontrolled infections, active or requiring antiviral therapy for liver and bile diseases). 9. Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol. 10. Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer). 11. Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions. 12. Patients with non-measurable tumors during treatment. 13. Any other condition that the investigator deems unsuitable for the participation of the subject in the study.

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Fourth Hospital of Hebei Medical University

Address:
City: Shijiazhuang
Zip: 050011
Country: China

Status: Recruiting

Contact:
Last name: Cuizhi Geng, M.D.

Phone: 0311-6669 6310
Email: gengcuizhi@hotmail.com

Start date: September 30, 2023

Completion date: December 1, 2025

Lead sponsor:
Agency: Hebei Medical University Fourth Hospital
Agency class: Other

Source: Hebei Medical University Fourth Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06107673