Breast cancer
Conditions
Interventions
Experiment group: Pyrotinib Maleate plus Dalpiciclib and AI
Control group:Dalpiciclib and AI
Sponsors
The Second Affiliated Hospital of Guagnzhou University of Chinese Medicine(Guangdong Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged =18,=70 years ; 2. Locally recurrent or metastatic breast cancer diagnosed by cytology or histology; 3. HR positive (ER and/or PR =10% positive), low HER2 expression (HER2++ and FISH negative or HER2+); 4. irst-line treatment with Dalpiciclib and AI with the efficacy evaluation as SD; 5. According to RECIST1.1 criteria, there is at least one measurable target lesion; 6. ECOG functional status score 0-2 points; 7. Sufficient bone marrow, liver and kidney (refer to the upper limit of normal value of each clinical trial center); 8. Willing to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced, symptomatic, visceral spread are at risk of developing life-threatening complications in the short term (including massive uncontrolled effusion [pleura, pericardium, peritoneum], pulmonary lymphangitis, and hepatic involvement in >50% of cases) patient); 2. Patients with primary central nervous system (CNS) malignant tumors or CNS metastases that have failed local therapy.; 3. Previous treatment with any CDK4/6 inhibitor; 4. Patients who have received drugs known to prolong the QT interval within 7 days before randomization; 5. Major surgery, chemotherapy, radiotherapy, any experimental drug or other anticancer treatment within 2 weeks before randomization; 6. Any other malignancy diagnosed within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 7. QTc>480 ms (based on average of three ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsades de pointes (TdP) ; 8. Uncontrolled electrolyte disturbances that can exacerbate the effects of QTc prolonging drugs (eg, hypocalcemia, hypokalemia, hypomagnesemia); 9. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome or any upper gastrointestinal surgery, including gastrectomy; 10. Patients with known allergies to AIs,0, pyrotinib, CDK4/6i components or excipients; 11. Known human immunodeficiency virus infection; 12. Suffering from other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities, such as may increase the risk of participating in the research or taking the experimental drug or may interfere with the research results, the researcher believes that the patient is not suitable to participate in this research; 13. Participate in other studies within 4 weeks before randomization; 14recent suicidal thoughts or behaviors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective response rate;Disease control rate;Changes in molecular markers; | — |
Countries
China
Contacts
Public ContactChen Qianjun
The Second Affiliated Hospital of Guagnzhou University of Chinese Medicine(Guangdong Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed