Actively Recruiting
Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment
Led by Fujian Cancer Hospital · Updated on 2026-03-12
258
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).
CONDITIONS
Official Title
Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older who are postmenopausal or premenopausal/perimenopausal willing to receive LHRH agonists
- Diagnosed with HR positive and HER2 negative breast cancer not suitable for surgery or radiation with curative intent
- Estrogen receptor-positive and/or progesterone receptor-positive tumor cells representing 1% or more of tumor cells
- HER2-negative by immunohistochemistry or in situ hybridization
- ECOG performance status score of 0 to 2
- New stage IV or recurrent metastatic breast cancer with visceral metastases, including visceral crisis
- Adequate bone marrow function with specified neutrophil, platelet, and hemoglobin levels
- Negative serum pregnancy test for women who are not postmenopausal or surgically sterile
- Willingness to abstain from sexual intercourse or use highly effective contraception during the study and for one year after last dose
- Voluntary participation, informed consent, good compliance, and willingness to follow up
You will not qualify if you...
- Previous treatment with CDK4/6 inhibitors and/or capecitabine
- Relapse within 2 years of adjuvant endocrine therapy
- Bone metastases alone without visceral metastases
- Active brain metastases
- HIV infection, AIDS, hepatitis B or C infection, or co-infection
- Major cardiac events or conditions within 6 months before enrollment
- Severe infection within 4 weeks before first dose or unexplained fever over 38.5°C during screening
- Inability to swallow, bowel obstruction, or other factors affecting drug administration
- Known allergy to study drugs or excipients
- History of allogeneic organ or hematopoietic stem cell transplantation
- History of psychotropic substance or drug abuse
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fujian Cancer Hosptial
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
C
Chuangui Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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