Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）
NCT ID: NCT06107673
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2023-09-30
2028-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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neoadjuvant endocrine group
Dalpiciclib: Take 125 mg once daily for 3 weeks, then stop for 1 week. Each cycle is completed in 4 weeks.
AI: Take according to the instructions provided.
Dalpiciclib
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.
Aromatase inhibitor
AI: Take according to the instructions provided.
neoadjuvant chemotherapy group
Docetaxel for injection: Administered as a 75 mg/m2 intravenous infusion Epirubicin hydrochloride for injection: Administered as a 75 mg/m2 intravenous infusion.
Cyclophosphamide for injection: Administered as a 500 mg/m2 intravenous infusion.
Docetaxel injection
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.
Epirubicin Hydrochloride Injection
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.
Cyclophosphamide injection
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.
Interventions
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Dalpiciclib
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.
Aromatase inhibitor
AI: Take according to the instructions provided.
Docetaxel injection
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.
Epirubicin Hydrochloride Injection
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.
Cyclophosphamide injection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Responsible Party
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Locations
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MA-BC-II-055
Identifier Type: -
Identifier Source: org_study_id
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