A Phase 2 interventional study of Apatinib and Dalpiciclib in Breast Cancer Metastatic, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Patients with SNF34subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of Apatinib in SNF4 subtype of HR
+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients had received no previous chemotherapy or targeted therapy for metastatic disease
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Exclusion Criteria:
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Apatinib and endocrine therapy.
Drug: Apatinib · Drug: Dalpiciclib · Drug: Fulvestrant/AI
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.
Drug: Dalpiciclib · Drug: Fulvestrant/AI
TKI
CDK4/6 inhibitor
Endocrine therapy
PFS
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
OS
time to death due to any cause
Time frame: Randomization to death from any cause, through the end of study (approximately 5 years)
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fudan University