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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Dalpiciclib
  • Endocrine therapy

Treatment groups

1,163 Participants
are divided into 1 treatment group