Trial Title:
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
NCT ID:
NCT05759572
Condition:
Breast Cancer Metastatic
Conditions: Official terms:
Breast Neoplasms
Apatinib
Fulvestrant
Conditions: Keywords:
first-line therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apatinib
Description:
TKI
Arm group label:
Cohort 1
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
CDK4/6 inhibitor
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Intervention type:
Drug
Intervention name:
Fulvestrant/AI
Description:
Endocrine therapy
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Summary:
This study is a prospective, open-label, phase II clinical study for patients with
HR+/HER2- advanced breast cancer.
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.
Criteria for eligibility:
Criteria:
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
- Page 3 of 4 [DRAFT] -
- 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:
- 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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Lei Fan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Wenjuan Zhang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Start date:
February 1, 2023
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo Medical Center Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai First Maternity and Infant Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai 6th People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759572
