Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Phase 2

Recruiting

• Conditions: Early Breast Cancer
• Interventions: Drug: Dalpiciclib; Drug: Endocrine therapy

• Registration Number: NCT06341894
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Study First Submitted: 2024-02-24
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2027-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1163

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Endocrine therapy	Dalpiciclib and endocrine therapy
Treatment	Dalpiciclib	Dalpiciclib and endocrine therapy

Primary Outcome Measures

Name	Time	Method
invasive Disease-free Survival (iDFS)	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 Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	From enrollment until time of events up to 3 years	Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
AEs and SAEs	From the first administration to one months after the last drug administration，up to one month	Adverse events and Adverse events and serious adverse events according to CACTE 5.0

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China