Actively Recruiting
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
Led by Henan Cancer Hospital · Updated on 2024-08-20
240
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.
CONDITIONS
Official Title
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed invasive breast cancer with metastatic disease confirmed by biopsy or clear metastasis evidence
- HR low expression defined as 1-50% ER by immunohistochemistry or ER <1% and PR ≥1%; includes ER 1-10% or ER-/PR-positive after careful evaluation
- HER2 negative confirmed by immunohistochemistry 0 or 1+, or 2+ with negative FISH
- At least one measurable tumor lesion
- No prior salvage chemotherapy for metastatic disease; first-line endocrine therapy allowed
- No previous CDK4/6 inhibitor use; adjuvant CDK4/6 treatment allowed if recurrence occurred more than 1 year after stopping
- ECOG performance status 0-1 with life expectancy over 12 weeks
- Adequate major organ function
- All adverse events resolved to grade 1 or less before enrollment
- No major organ dysfunction or heart disease
- Women and men of childbearing potential agree to use contraception before and during study participation
You will not qualify if you...
- Symptomatic or uncontrolled brain or leptomeningeal metastases; stable brain metastases allowed after treatment and no symptoms
- Radiotherapy, chemotherapy, major surgery, targeted therapy, or immunotherapy within 2 weeks before enrollment; endocrine therapy within 1 week; nitrosourea or mitomycin chemotherapy within 6 weeks
- Participation in other new drug clinical trials within 4 weeks before enrollment
- Uncontrolled third space effusion not manageable by drainage or pneumatic methods
- Other malignant tumors within past 3 years except certain skin or cervical cancers
- Serious or uncontrolled diseases including active viral infections (HIV, active HBV, hepatitis C), severe cardiovascular disease, severe infection within 4 weeks, or unexplained fever
- History of psychotropic drug abuse, mental disorders, swallowing or absorption dysfunction
- Other diseases that endanger patient safety or study completion per investigator judgment
- Known allergy to study regimen components or history of immunodeficiency
- Pregnant or breastfeeding women
- Deemed unsuitable for study inclusion by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
M
Min Yan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here