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

RecruitingPhase 2Ages 18 Years - 75 YearsFemaleThe First Affiliated Hospital with Nanjing Medica…
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Dalpiciclib
  • Endocrine therapy
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Where

1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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