Recruiting
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
ClinicalTrials.gov IDNCT06341894
PhasePHASE2
Enrollment1163
SponsorThe First Affiliated Hospital with Nanjing Medical University
Age18 Years
SexFEMALE
Conditions studied
Early Breast Cancer
About this study
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Interventions
- Drug: Dalpiciclib — CDK4/6 inhibitor dalpiciclib, 100mg orally qd
- Drug: Endocrine therapy — Fulvestrant/AI
Primary outcomes
- invasive Disease-free Survival (iDFS) (From enrollment until time of events up to 3 years)
Eligibility information
Inclusion Criteria:
* Patient is ≥ 18 years-old
* Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
* Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
* Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
* Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
* From operation to enrollment should not exceed 12 months
* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
* metastatic disease (Stage IV) or inflammatory breast cancer
* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
* Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
* A history of allergy to the drugs in this study;
* Unable or unwilling to swallow tablets
* History of gastrointestinal disease with diarrhea as the major symptom.
Study locations
- The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.