NCT07162259Not yet recruitingPhase 4
Cohort Study on Sequential ADC Therapy in HR-positive/HER2-negative Advanced Breast Cancer
Real-world Cohort Study on Sequential Therapy With ADC Drugs Following Progression of Endocrine Therapy Guided by Molecular Biomarkers in HR-positive/HER2-negative Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 growth factor receptor 2-negative) breast cancer. However, the optimal treatment strategy after CDK4/6i progression remains unclear. In recent years, antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have demonstrated significant activity in HR+/HER2- breast cancer, providing new options post-CDK4/6i progression. Yet, the optimal sequencing of different ADCs (e.g., SG followed by T-DXd vs. T-DXd followed by SG) after CDK4/6i failure remains uncertain. Determining how to further optimize treatment selection to prolong survival and improve quality of life has become a key research focus in clinical practice. This study aims to explore the efficacy, safety, and potential resistance mechanisms of biomarker-guided sequential ADC therapy (e.g., SG→T-DXd vs. T-DXd→SG) following CDK4/6i progression. The findings may guide clinical decision-making and provide evidence for precision medicine.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 18 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Yan Xue
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07162259
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 1 Oct 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with topoisomerase 1 (TOP-1) inhibitor-based therapy;
- History of moderate to severe interstitial lung disease (ILD) with concurrent pulmonary insufficiency;
Other illness
- Severe cardiac, hepatic, or renal dysfunction or other serious comorbidities;
- 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);
Other
- Symptomatic brain metastases;
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xi'an International Medical Center Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.