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Active, not recruitingNCT05759572Updated Sep 16, 2026

Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer

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

Phase
Phase 2
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
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Study summary

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Read the detailed description

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.

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Conditions studied

  • Breast Cancer Metastatic

Keywords

  • first-line therapy
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In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Females ≥18 years and ≤ 75 years old;
  • Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
  • Subtype of similarity network fusion-4 (SNF-4) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
  • Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL;
  • Patients had received no previous chemotherapy or targeted therapy for metastatic disease

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  • Has adequate liver function and kidney function: serum creatinine
  • ECOG score ≤ 2 and life expectancy ≥ 3 months;
  • Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up

Exclusion criteria

Exclusion Criteria:

  • Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
  • Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
  • Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
  • is pregnant or breast feeding;
  • Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
145 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Apatinib and endocrine therapy.

    Drug: Apatinib · Drug: Dalpiciclib · Drug: Fulvestrant/AI

  • Active comparator
    Cohort 2

    In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.

    Drug: Dalpiciclib · Drug: Fulvestrant/AI

Interventions

  • DrugApatinib

    TKI

  • DrugDalpiciclib

    CDK4/6 inhibitor

  • DrugFulvestrant/AI

    Endocrine therapy

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What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. OS

    time to death due to any cause

    Time frame: Randomization to death from any cause, through the end of study (approximately 5 years)

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Study locations

1 site
  • Breast cancer institute of Fudan University Cancer Hospital
    Shanghai, Shanghai Municipality 200032, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05759572
Lead sponsor
Fudan University
Collaborators
Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-Sen University Cancer Center, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Cancer Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Affiliated Hospital of Nantong University, The Third Affiliated Hospital of Nanchang University, Hebei Medical University Fourth Hospital, The First Hospital of Jilin University
Responsible party
Zhimin Shao (Professor, Fudan University) — Principal investigator
First posted
Mar 8, 2023
Start date
Mar 1, 2023
Primary completion
Jul 21, 2026
Completion
Jul 1, 2027 (estimated)
Last update
Sep 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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