Status:
NOT_YET_RECRUITING
Cohort Study on Sequential ADC Therapy in HR-positive/HER2-negative Advanced Breast Cancer
Lead Sponsor:
Yan Xue
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-85 years
Phase:
PHASE4
Brief Summary
The combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and endocrine therapy is the standard first-line treatment for advanced HR+ (hormone receptor-positive)/HER2- (human epidermal growt...
Eligibility Criteria
Inclusion
- Adult patients ≥18 years old;
- Histologically or cytologically confirmed HR+/HER2- (HER2 IHC 0/IHC 1+ or IHC 2+ with FISH-negative) locally advanced unresectable or metastatic breast cancer, as defined by ASCO/CAP guidelines;
- Prior treatment with CDK4/6i combined with endocrine therapy, with radiologically confirmed disease progression;
- Presence of evaluable lesions;
- Received ≤2 lines of chemotherapy for advanced disease;
- Adequate organ function and performance status (ECOG score ≤2);
- Signed informed consent.
Exclusion
- Previous treatment with topoisomerase 1 (TOP-1) inhibitor-based therapy;
- Severe cardiac, hepatic, or renal dysfunction or other serious comorbidities;
- History of moderate to severe interstitial lung disease (ILD) with concurrent pulmonary insufficiency;
- Symptomatic brain metastases;
- History of allergy to key components of the investigational ADC drugs (e.g., payload, antibody, or linker);
- Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or a history of intestinal obstruction or gastrointestinal (GI) perforation;
- Uncontrolled cardiovascular diseases (e.g., NYHA Class III/IV heart failure, myocardial infarction within 6 months);
- Active infections (e.g., HIV, active HBV/HCV infection);
- Pregnant or lactating women.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07162259
Start Date
October 1 2025
End Date
December 31 2027
Last Update
September 9 2025
Active Locations (1)
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1
Xi'an International Medical Center Hospital
Xi'an, China