Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
NCT ID: NCT06341894
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
1163 participants
INTERVENTIONAL
2023-11-17
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Dalpiciclib and endocrine therapy
Dalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Endocrine therapy
Fulvestrant/AI
Interventions
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Dalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Endocrine therapy
Fulvestrant/AI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Liu Xiaoan
Professor
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OBU-II-BC-126
Identifier Type: -
Identifier Source: org_study_id
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