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

NCT06107673 | Recruiting Phase 2

• 1 other identifier: MA-BC-II-055
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

HER2- ER+; Neoadjuvant therapy; Dalpiciclib

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response

  Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.

  6 months

Secondary Outcomes (7)

• Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  6 months

• Evaluation of the number of patients with a Residual Cancer Burden (RCB) 0-I index

  6 months

• Evaluation of the number of patients with PEPI 0

  6 months

• Percentage of Participants With Pathologic Complete Response (pCR)

  6 months

• Calculation of the rates of breast conservation therapy in the two arms with regard to the initially planned surgery.

  6 months

Study Arms (2)

neoadjuvant endocrine group

EXPERIMENTAL

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.

Drug: Dalpiciclib; Drug: Aromatase inhibitor

neoadjuvant chemotherapy group

ACTIVE COMPARATOR

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.

Drug: Docetaxel injection; Drug: Epirubicin Hydrochloride Injection; Drug: Cyclophosphamide injection

Interventions

Dalpiciclib DRUG

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.

Also known as: SHR6390

neoadjuvant endocrine group

Aromatase inhibitor DRUG

AI: Take according to the instructions provided.

Also known as: AI

neoadjuvant endocrine group

Docetaxel injection DRUG

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.

neoadjuvant chemotherapy group

Epirubicin Hydrochloride Injection DRUG

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.

neoadjuvant chemotherapy group

Cyclophosphamide injection DRUG

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.

neoadjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form to participate in the clinical research.
• Confirmed postmenopausal females diagnosed with invasive breast cancer.
• Clinical stage T1-3N1M0.
• 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.
• No prior breast cancer-related treatment.
• No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I).
• ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction.
• 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.
• 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.
• 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.
• Exhibits good compliance.

You may not qualify if:

• 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.
• 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.
• Patients with bilateral breast cancer or inflammatory breast cancer.
• Patients with metastatic (stage IV) breast cancer at initial diagnosis.
• Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.
• Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc.
• 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.
• 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).
• Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol.
• 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).
• Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions.
• Patients with non-measurable tumors during treatment.
• Any other condition that the investigator deems unsuitable for the participation of the subject in the study.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dalpiciclib; Aromatase Inhibitors; Docetaxel; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

lina zhang

CONTACT

15830981676; linazh_001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: October 30, 2023
• Study Start: September 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)