breast cancer
Conditions
Interventions
Group A :Switching from Trastuzumab Deruxtecan to Capivasertib plus Fulvestrant)
Group B:Switching from Capivasertib plus Fulvestrant to Trastuzum
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form with good treatment compliance. 2. Aged between 18 and 75 years old inclusive. 3. Male or female patients with histologically confirmed HR+/HER2-low metastatic breast cancer, premenopausal and postmenopausal patients are both eligible. 4. Confirmed presence of PIK3CA, AKT1 or PTEN mutation via prior genetic testing, and original test reports are available. Reduced PTEN expression confirmed only by IHC shall not serve as enrollment evidence. 5. Metastatic lesions confirmed by MRI or contrast-enhanced CT. There shall be at least one measurable lesion assessed per RECIST 1.1 criteria. 6. Disease progression occurred after prior treatment with CDK4/6 inhibitor combined with endocrine therapy. Patients shall have received no more than 2 lines of endocrine therapy for advanced/metastatic disease. Recurrence and metastasis during adjuvant endocrine therapy or within 1 year after treatment discontinuation shall regard adjuvant therapy as first-line treatment. No more than 1 line of prior chemotherapy is permitted. 7. FFPE specimens of primary or metastatic lesions should be available for exploratory analysis. Unavailability of specimens will not affect subject enrollment. 8. Glycemic control: HbA1c level less than 8.0%. Diabetic patients shall achieve well-controlled blood glucose. 9. Possess adequate bone marrow reserve and normal vital organ function. 10. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to enrollment, and agree to comply with contraception requirements throug; 11. ECOG performance status 0-2
Exclusion criteria
Exclusion criteria: 1. Previously treated with PI3K/AKT/mTOR inhibitors or ADC drugs; 2. Known allergy to the drugs or excipients involved in this trial; 3. Pregnant or breastfeeding women; 4. Had major surgery within 4 weeks before starting study medication and not fully recovered (minor surgeries like tumor biopsy, thoracentesis, or venous catheterization are allowed); 5. Patients with severe systemic diseases and/or uncontrolled infections; 6. Conditions that the researcher believes seriously endanger patient safety or interfere with completing the study (e.g., severe hypertension, diabetes, thyroid disease, coexisting hepatitis B/C, and other active infections); 7. History of other malignancies; 8. Mental illness or cognitive impairment that prevents completing the trial and follow-ups; 9. Other cases that researchers judge as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate (CBR);nd Duration of Response (DOR).;bjective Response Rate (ORR),; | — |
Countries
China
Contacts
Public ContactWenming Cao
Zhejiang Cancer Hospital
Outcome results
None listed