Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study

This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III).

Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms; Breast Diseases; Endocrine Breast Diseases; HR+/HER2- Breast Cancer; CDK4/6 Inhibitor; Dalpiciclib
• Intervention / Treatment: Drug: Dalpiciclib 125mg; Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen; Drug: Dalpiciclib 100mg

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chuangui Song, doctor; Phone Number: 13960709993; Email: songcg1971@outlook.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Cancer Hosptial
      • Contact: Chuangui Song, doctor; Phone Number: 13960709993; Email: songcg1971@outlook.com
  • Sichuan
    • Chengdu, Sichuan, China, 618099
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Contact: Ting Luo, doctor; Phone Number: 18602866299; Email: tina621@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal/perimenopausal.
2. Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and/or PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH or CISH testing, with no amplification).

3. Patients with histologically confirmed invasive breast cancer at clinical/pathological stages II-III.

   Note: For stage IIA, N1 is required, or N0 with Grade 3 or Grade 2 tumors combined with high-risk factors such as Ki-67 ≥20% or positive genetic testing (including but not limited to high-risk results in the 21-gene test). If the patient has previously received neoadjuvant therapy, the clinical stage at the time before neoadjuvant therapy must meet the above criteria.

4. Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.
5. The time interval from surgery to enrollment must not exceed 12 months.
6. Patients who have received radiotherapy must have recovered from the acute effects of radiotherapy, and there must be at least 14 days of washout period from the end of radiotherapy to enrollment.
7. Patients who have previously received chemotherapy must have recovered from the acute adverse effects of chemotherapy before enrollment ([CTCAE] grade ≤1), except for hair loss or grade 2 peripheral neuropathy.There must be a washout period of at least 21 days between the last administration of chemotherapy and enrollment in the study. 8. The Eastern Cooperative Oncology Group performance status score must be 0-1. 9. The functions of major organs must meet the following requirements: a) Blood tests: neutrophils (ANC) ≥1.5×10^9/L; platelet count (PLT) ≥90×10^9/L; hemoglobin (Hb) ≥90 g/L. b) Blood biochemistry tests: total bilirubin (TBIL) ≤2.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN. c) 12-lead electrocardiogram: QT interval corrected using the Fridericia method (QTcF) < 470 ms in females (QTcF calculation formula: QTcF = QT/(RR^1/3)). Participants must voluntarily agree to participate in the study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up assessments.

Exclusion Criteria:

1. Stage IV breast cancer or recurrent/metastatic breast cancer, or inflammatory breast cancer;
2. A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.
3. Participating in other clinical trials simultaneously;
4. Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;
5. Individuals with a known history of allergy to any component of this medication;
6. A history of immunodeficiency, including a positive HIV test result, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
7. Any history of heart disease, including: (1) angina pectoris; (2) arrhythmias that require medical treatment or are clinically significant; (3) myocardial infarction; (4) heart failure; (5) any other heart disease deemed by the study investigators to be inappropriate for participation in this trial.
8. Pregnant or lactating female patients; 9. Any other circumstances in which the researchers deem the participant unsuitable for participating in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Column 1; Dalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle.It was administered for 2 years. Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AI), fulvestrant, tamoxifen, toremifene, etc.	Drug: Dalpiciclib 125mg; Dalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 2 years.; Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen; Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.
Experimental: Column 2; Dalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years. Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.	Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen; Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.; Drug: Dalpiciclib 100mg; Dalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year invasive disease-free survival	Defined as the time from the date of enrollment until the first occurrence of one of the following iDFS events: invasive ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, distant metastasis, and death from any cause.	Observed from enrollment through 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant Disease- Free Survival	From the date of enrollment until the first distant relapse or death from any cause.	Observed from enrollment through 3 years.
overall survival	Time from enrollment to death from any cause.	Observed from enrollment through 3 years.
Patient Reported Outcomes	Collected by EORCT QLQ-C30 Quality of Life Scale	Evaluations are conducted every 3 months in the first year, and every half month in the second and third years.
Safety Results	Record adverse events (AEs) and serious adverse events (SAEs) separately in accordance with the NCI CTC AEv5.0 criteria.	From the time of enrollment until 30 days after the completion of the medication regimen

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Breast Diseases; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Nitriles; Triazoles; Stilbenes; Benzylidene Compounds; Anastrozole; Tamoxifen; exemestane; dalpiciclib
• Other Study ID Numbers: OBU-BC-Ⅱ-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No