Actively Recruiting
Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-12-31
45
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, prospective phase II clinical trial evaluates the efficacy and safety of sequential Trastuzumab rezetecan followed by dalpiciclib plus endocrine therapy (fulvestrant or aromatase inhibitors) in 45 patients with HR+/HER2-low/ultra-low advanced breast cancer. Enrolled patients will receive Trastuzumab rezetecan monotherapy for 6-8 cycles until clinical benefit, then transition to CDK4/6 inhibitors with endocrine therapy until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), overall survival (OS), and treatment-related adverse events (TRAEs). The study will be conducted at Sun Yat-sen Memorial Hospital and collaborating centers.
CONDITIONS
Official Title
Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Pathologically confirmed HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-negative) or HER2-ultra-low (IHC 0 with membranous staining >0 but <1+)
- Unresectable or metastatic breast cancer, including recurrent disease deemed unresectable
- Disease progression after prior endocrine therapy plus CDK4/6 inhibitor in advanced or metastatic setting
- Progression within 12 months of adjuvant endocrine therapy plus CDK4/6 inhibitor allowed
- No more than one prior line of endocrine therapy and one prior line of chemotherapy for advanced disease
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function including hematologic, hepatic, renal, cardiac (LVEF ≥50%), and QTcF <470 ms
- Voluntary participation with signed informed consent
You will not qualify if you...
- Prior anti-HER2 therapy at any stage, including HER2 antibody-drug conjugates like T-DM1 or T-DXd
- Significant cardiac disease such as heart failure, systolic dysfunction (LVEF <50%), high-risk or treated angina, serious arrhythmias, clinically significant valvular disease, or recent transmural myocardial infarction
- Uncontrolled hypertension with systolic >150 mmHg or diastolic >100 mmHg
- History of non-infectious interstitial lung disease (ILD) requiring steroids or current/suspected ILD
- Conditions impairing oral drug absorption, including dysphagia, chronic diarrhea, or intestinal obstruction
- Uncontrolled third-space effusions not manageable by drainage
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during and for 7 months after treatment
- Severe comorbidities interfering with treatment such as active hepatitis B virus infection or pulmonary infections requiring therapy
- Any other condition considered unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
J
JianLi Zhao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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