NCT06341894RecruitingPhase 2
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country1,163 target enrollmentStarted: November 17, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 1,163
- Locations
- 1
- Primary Endpoint
- invasive Disease-free Survival (iDFS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment
Experimental
Dalpiciclib and endocrine therapy
Intervention: Dalpiciclib (Drug)
Treatment
Experimental
Dalpiciclib and endocrine therapy
Intervention: Endocrine therapy (Drug)
Outcomes
Primary Outcomes
invasive Disease-free Survival (iDFS)
Time Frame: From enrollment until time of events up to 3 years
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause
Secondary Outcomes
- Disease-free Survival (DFS)(From enrollment until time of events up to 3 years)
- AEs and SAEs(From the first administration to one months after the last drug administration，up to one month)
Investigators
Liu Xiaoan
Professor
The First Affiliated Hospital with Nanjing Medical University
Study Sites (1)
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