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

NCT06341894 | Recruiting Phase 2

• 1 other identifier: OBU-II-BC-126
• Study Type: interventional
• Target: 1,163
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Dalpiciclib and endocrine therapy

Drug: Dalpiciclib; Drug: Endocrine therapy

Interventions

Dalpiciclib DRUG

CDK4/6 inhibitor dalpiciclib, 100mg orally qd

Also known as: CDK4/6 inhibitor

Treatment

Endocrine therapy DRUG

Fulvestrant/AI

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• From operation to enrollment should not exceed 12 months
• Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dalpiciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaoan Liu, Professor

CONTACT

025-68308162; liuxiaoan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: April 2, 2024
• Study Start: November 17, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)