Actively Recruiting
Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
Led by Hunan Cancer Hospital · Updated on 2025-07-11
300
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i Progression in the Real World has significant implications. This study is an observational, real-world study. It plans to include over 300 eligible HR+/HER2- metastatic breast cancer patients who are currently receiving or planning to receive endocrine therapy regimens containing CDK4/6 inhibitors. This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6 inhibitors combined with endocrine therapy, based on clinical guideline consensus. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be chosen by the physician, and the efficacy and safety of subsequent treatment will be evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some patients.
CONDITIONS
Official Title
Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, including postmenopausal or pre/perimenopausal females and male patients
- Female patients must meet one of the following: prior bilateral oophorectomy, age 60 or older, natural postmenopausal status with consistent hormone levels, or pre/perimenopausal willing to receive LHRH agonist during the study
- Pathologically confirmed hormone receptor-positive breast cancer with localized recurrence or metastasis not suitable for curative surgery or radiation
- Estrogen receptor-positive and/or progesterone receptor-positive tumor cells ≥ 1%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No prior systemic treatment or currently receiving CDK4/6 inhibitors as first-line treatment for advanced disease
- Negative serum pregnancy test within 28 days before enrollment for reproductive-age females
- Willingness to use medically approved contraception during the study and for 1 year after last dose
- Non-pregnant and non-lactating females
- Not participating in any other ongoing study
- Provided informed consent and able to comply with study visits, treatment plan, and tests
You will not qualify if you...
- Severe or uncontrolled systemic illnesses such as uncontrolled hypertension, active bleeding, infections (hepatitis B, hepatitis C, HIV), or severely impaired bone marrow or organ function
- Not recovered from prior treatment toxicity of CTCAE grade 3 or higher at start of CDK4/6 inhibitor therapy
- Known allergy to CDK4/6 inhibitors or related drugs
- Deemed unsuitable for enrollment by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
N
Ning Xie, Dr.
CONTACT
T
Ting Liu, Ms.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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