Actively Recruiting
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-04-02
1163
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older
- Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- Patient has histologically confirmed hormone receptor-positive, HER2-negative early breast cancer (ER and/or PR ≥10%)
- Histologically confirmed invasive breast cancer with anatomic stages IIA to IIIC (T2-4N0-3M0), including stage IIA only with T1N1M0
- Patients may have had neoadjuvant or adjuvant chemotherapy or radiotherapy
- Time from surgery to enrollment is no more than 12 months
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
You will not qualify if you...
- Presence of metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current malignant tumors except for successfully treated basal or squamous cell skin carcinoma or carcinoma in situ of the cervix
- Clinically relevant cardiovascular disease such as uncontrolled or symptomatic angina, significant arrhythmias, congestive heart failure, transmural myocardial infarction, or uncontrolled hypertension (≥180/110)
- Allergy to study drugs
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
X
Xiaoan Liu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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