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

Early Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341894
• Other study ID #: OBU-II-BC-126
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2023
• Est. completion date: June 2029

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiaoan Liu, Professor
• Phone: 025-68308162
• Email: liuxiaoan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1163
• Est. completion date: June 2029
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Drug:
• Dalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
• Endocrine therapy
Fulvestrant/AI

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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