Actively Recruiting
Apatinib in Combination With CDK4/6 Inhibitor and Endocrine Therapy as First-line Treatment for HR+/HER2- Advanced Breast Cancer
Led by Fudan University · Updated on 2024-02-06
145
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Apatinib combined with CDK4/6 inhibitor and endocrine therapy in treating patients with hormone receptor-positive, HER2-negative advanced breast cancer, specifically the SNF4 subtype. This phase II open-label clinical study aims to prepare for future larger randomized phase III trials by assessing treatment outcomes in this specific breast cancer group. Participants are divided into two groups: one group receives Dalpiciclib (a CDK4/6 inhibitor) combined with Apatinib and endocrine therapy, while the other group receives Dalpiciclib with endocrine therapy only. Treatments are administered as first-line therapy, focusing on patients with locally advanced or metastatic disease that cannot be treated surgically. During the study, participants will be monitored for progression-free survival, overall response rate, clinical benefit rate, and overall survival over approximately five years. Researchers will assess disease progression or death as primary outcomes and follow patients with regular evaluations, including imaging and lab tests. Participants must consent to follow-up and comply with study procedures throughout the trial.
CONDITIONS
Brief Title
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Histologically confirmed hormone receptor-positive, HER2-negative invasive breast cancer
- SNF-4 subtype confirmed by specific pathology department
- Locally advanced or recurrent metastatic breast cancer not suitable for surgery
- Measurable disease or specific bone lesions per RECIST v1.1 criteria
- Adequate bone marrow function (specified blood counts)
- No prior chemotherapy or targeted therapy for metastatic disease
- Adequate liver and kidney function
- ECOG performance status 0 to 2 with life expectancy of at least 3 months
- Voluntary informed consent and agreement to follow-up
You will not qualify if you...
- Previous chemotherapy, radiotherapy, immunotherapy, or surgery for metastatic disease (except outpatient surgery)
- Symptomatic, untreated, or actively progressing central nervous system metastases requiring symptom control
- Significant cardiovascular disease within the last 6 months
- Pregnant or breastfeeding
- Malignant tumors within the past 5 years except cured basal cell carcinoma or cervical carcinoma in situ
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or discontinuation, up to approximately 5 years
Participants receive Dalpiciclib combined with endocrine therapy, with or without Apatinib, as first-line treatment for advanced breast cancer.
Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao
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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