Actively Recruiting
Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer
Led by Hebei Medical University Fourth Hospital · Updated on 2025-09-11
420
Participants Needed
1
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.
CONDITIONS
Official Title
Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Postmenopausal or premenopausal female or male patients
- Female patients must meet one of the following: previous bilateral oophorectomy; or age 60 years or older; or natural postmenopausal status with hormone levels at postmenopausal levels; or premenopausal/perimenopausal and willing to receive LHRH agonist therapy during the study
- Pathologically confirmed hormone receptor-positive breast cancer with local recurrence or metastasis not suitable for surgery or radiation aimed at cure
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Negative serum pregnancy test within 28 days before enrollment for women of childbearing age
- Willingness of male and female patients to use medically recognized effective contraception during the study and for one year after last dose
- Non-pregnant and non-lactating female patients
- Not participating in other ongoing studies at the same time
- Able and willing to provide informed consent and comply with study visits, treatment plan, laboratory tests, and procedures
You will not qualify if you...
- Presence of serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections such as hepatitis B, C, or HIV, or severely impaired bone marrow or organ function
- Not recovered from any grade 3 or higher toxicity from previous treatment at time of starting dalpiciclib
- Known hypersensitivity to dalpiciclib, its excipients, or chemically similar drugs
- Considered unsuitable for inclusion by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Fourth hospital of Hebei University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
Research Team
C
cuizhi Geng Cuizhi Geng, archiater
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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