Actively Recruiting
Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)
Led by Fudan University · Updated on 2024-06-07
184
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining Apatinib with standard first-line endocrine therapy for women with the HR+/HER2- SNF4 subtype of advanced breast cancer. This phase III randomized, open-label study aims to explore whether adding Apatinib to CDK4/6 inhibitors and endocrine therapy improves outcomes for this specific breast cancer subtype. Participants are assigned to one of two groups: one receiving Apatinib combined with a CDK4/6 inhibitor and endocrine therapy, and the other receiving only a CDK4/6 inhibitor with endocrine therapy. The endocrine therapies include Letrozole, Anastrozole, Exemestane, or Fulvestrant, with postmenopausal women also using Goserelin. The study will track participants for approximately five years to assess treatment effects. During the study, participants will undergo regular evaluations including tumor assessments according to RECIST 1.1 criteria. Researchers will measure progression-free survival, clinical benefit rate, objective response rate, overall survival, and safety over about five years. Participants' organ functions and overall health status will be closely monitored, with adherence to contraceptive requirements for fertile women. The study involves detailed follow-up to monitor both effectiveness and tolerability of the treatments.
CONDITIONS
Brief Title
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Female patients with pathologically confirmed HR+/HER2- breast cancer
- SNF4 subtype confirmed by digital pathology of H&E sections
- Locally advanced breast cancer not suitable for radical local therapy or metastatic breast cancer without prior adjuvant CDK4/6 inhibitor therapy within one year
- No prior therapy for advanced or metastatic breast cancer
- At least one measurable lesion not previously treated with radiation and evaluable by RECIST 1.1
- Normal main organ functions meeting specified blood and biochemical criteria
- ECOG performance status of 0 or 1 with expected survival over 3 months
- Fertile females must use approved contraception during treatment and for 3 months after last study drug use
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Uncontrolled central nervous system metastasis requiring glucocorticoids or mannitol
- History of significant or uncontrolled heart disease including recent heart attack, heart failure, angina, or ventricular arrhythmia
- Radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before study drug administration
- Pregnant or lactating women
- Other malignancies within the past 3 years except cured skin basal cell carcinoma or cervical carcinoma in situ
- Significant comorbid medical conditions including mental illness affecting study participation
- Known allergies to study drug components or monoclonal antibodies
- Investigator's judgment that patient is unsuitable for study participation for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 years
Participants receive Apatinib combined with CDK4/6 inhibitor and endocrine therapy or CDK4/6 inhibitor with endocrine therapy as first-line treatment for HR+/HER2- advanced breast cancer.
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
P
Peng Ji, MD
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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