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 ? Clinical Trial
- Conditions
- Advanced Breast CancerTreatmentHR Low/HER2 Negative
- Registration Number
- NCT06176534
- Lead Sponsor
- Henan Cancer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria:<br><br> 1. age =18 years old; Invasive breast cancer with metastatic disease confirmed by<br> histological or cytological examination; Patients without pathologically or<br> cytologically confirmed metastatic disease should have clear evidence of metastasis<br> by physical examination or radiological studies;<br><br> 2. The most recent pathological report of biopsy confirmed HR low expression and HER2<br> negative.<br><br> 1. HR low expression was defined as 1-50% ER expression by immunohistochemistry<br> (IHC); Or ER<1% and PR=1%; Patients with ER expression of 1-10% or ER-/<br> PR-positive patients were eligible for inclusion after careful evaluation by<br> the investigator, and those with a small tumor burden and candidates for<br> endocrine therapy were eligible.<br><br> 2. HER2-negative definition: IHC 0 or 1+; If the IHC was 2+, it was confirmed<br> negative by fluorescence in situ hybridization (FISH).<br><br> 3. at least one measurable lesion;<br><br> 4. No previous salvage chemotherapy for metastatic disease was required, and first-line<br> endocrine therapy was allowed;<br><br> 5. no previous CDK4/6 inhibitor; For adjuvant CDK4/6i treatment, recurrence and<br> metastasis were required more than 1 year after drug withdrawal.<br><br> 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, life expectancy<br> is more than 12 weeks;<br><br> 7. Adequate function of major organs.<br><br> 8. All adverse events recovered to grade 1 or less before enrollment (NCI CTCAE version<br> 5.0);<br><br> 9. patients without major organ dysfunction and heart disease;<br><br> 10. Women and men of childbearing potential must agree to use appropriate contraception<br> before and during study participation.<br><br>Exclusion Criteria:<br><br> 1. symptomatic, uncontrolled brain or leptomeningeal metastases; Patients who had<br> received previous systemic radical treatment for brain metastases (radiotherapy or<br> surgery), if stable disease had been maintained for at least 1 month as confirmed by<br> imaging, and if systemic hormone therapy (dose 10mg/ day prednisone or other<br> effective hormones) for more than 2 weeks without clinical symptoms.<br><br> 2. patients received radiotherapy, chemotherapy, major surgery, targeted therapy or<br> immunotherapy within 2 weeks before enrollment; Patients received endocrine therapy<br> within 1 week before enrollment. Chemotherapy with nitrosourea or mitomycin was<br> administered within 6 weeks before enrollment.<br><br> 3. participated in other clinical trials of new drugs within 4 weeks before enrollment;<br><br> 4. there can not be controlled by drainage or pneumatic methods third space effusion;<br><br> 5. patients with other malignant tumors within the past 3 years, excluding radical<br> cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell<br> carcinoma;<br><br> 6. suffering from serious or uncontrolled diseases, including but not limited to: 1)<br> active viral infection, such as HIV or HBV active (HbsAg positive and HBV-DNA=103,<br> hepatitis C antibody positive); 2) history of severe cardiovascular disease:<br> uncontrolled hypertension; Myocardial infarction, unstable arrhythmia, congestive<br> heart failure, pericarditis, myocarditis, etc. Patients with NYHA class ?-? cardiac<br> dysfunction, or left ventricular ejection fraction (LVEF) 50% by echocardiography;<br> 3) severe infection (e.g., intravenous antibiotic, antifungal, or antiviral therapy<br> according to clinical practice) within 4 weeks prior to the first dose or<br> unexplained fever during screening/before the first dose; 38.3°C (fever due to<br> cancer, as judged by the investigator, was eligible);<br><br> 7. patients with a history of psychotropic drug abuse and unable to abstain or with<br> mental disorders; Or accompanied by swallowing and absorption dysfunction;<br><br> 8. patients with other concomitant diseases that seriously endanger the safety of<br> patients or affect the completion of the study according to the judgment of the<br> investigators;<br><br> 9. patients with known history of allergy to the components of this regimen; A history<br> of immunodeficiency, including testing positive for HIV, HCV or other acquired or<br> congenital immunodeficiency disorders, or a history of organ transplantation;<br><br> 10. pregnant or lactating women;<br><br> 11. Patients deemed unsuitable for inclusion by the investigators.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR by investigator using RECIST Guideline (Version 1.1)
- Secondary Outcome Measures
Name Time Method PFS;Adverse events;OS