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NCT Number: NCT06341894

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

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Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Xiaoan Liu, Professor

CONTACT

[email protected]

025-68308162

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dalpiciclib

Drug

CDK4/6 inhibitor dalpiciclib, 100mg orally qd

Other names: CDK4/6 inhibitor

endocrine therapy

Drug

Fulvestrant/AI

Primary outcomes

  1. 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

  1. Disease-free Survival (DFS)

    Time frame: 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.

  2. AEs and SAEs

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoan Liu, Professor

CONTACT

[email protected]

025-68308162

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Apr 2, 2024
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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