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

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative 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.

Study Overview

• Status: Recruiting
• Conditions: Early Breast Cancer
• Intervention / Treatment: Drug: Dalpiciclib; Drug: Endocrine therapy

• Study Type: Interventional
• Enrollment (Estimated): 1163
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoan Liu, Professor; Phone Number: 025-68308162; Email: liuxiaoan@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Xiaoan Liu, Professor; Phone Number: 025-68308162; Email: liuxiaoan@126.com

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Dalpiciclib and endocrine therapy	Drug: Dalpiciclib; CDK4/6 inhibitor dalpiciclib, 100mg orally qd; Other Names: CDK4/6 inhibitor; Drug: Endocrine therapy; Fulvestrant/AI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive Disease-free Survival (iDFS)	Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause	From enrollment until time of events up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	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.	From enrollment until time of events up to 3 years
AEs and SAEs	Adverse events and Adverse events and serious adverse events according to CACTE 5.0	From the first administration to one months after the last drug administration，up to one month

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OBU-II-BC-126

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