Advanced Breast Cancer
Conditions
Keywords
XZP-3287, HR positive and Her2 negative, recurrent/metastatic breast cancer
Brief summary
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
Interventions
DRUGXZP-3287+Fulvestrant
XZP-3287 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease
Placebo 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease
Sponsors
Xuanzhu Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients aged ≥18 years and ≤75 years old; 2. Patient is in the menopausal state； 3. Pathologically-confirmed HR positive and Her2 negative Breast Cancer; 4. Locally advanced stage, recurrence or metastasis breast cancer; 4.1 Disease progression after previous endocrine therapy； 4.2 One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; 5. At least one measurable lesion (based on RECIST v1.1) or only bone metastases; 6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 7. Adequate organ and marrow function; 8. Patient of childbearing age must undergo a serum pregnancy test within 14 days before randomization, and the result is negative; patient is willing to use a medically approved high-efficiency contraceptive method during the study period and within 6 months after the last study drug treatment; 9. Patient with acute toxic reactions caused by previous anti-tumor treatments or surgical operations were alleviated to grade 0 to 1 (NCI-CTCAE v5.0), or to the level specified by the enrollment criteria; 10. Patient has signed informed consent before any trial related activities.
Exclusion criteria
1. Patient with visceral crisis, inflammatory breast cancer, or brain metastases, except for patient with stable brain metastases; 2. Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment; 3. Patient who received prior treatment with mTOR inhibitors, CDK4/6 inhibitors or fulvestrant; 4. Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment； 5. Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer; 6. Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer; 7. Patient who used bisphosphonates or RANKL inhibitors within 7 days before enrollment, patient who have started treatment during the study should not change the method of use; 8. Any other malignant tumor has been diagnosed within 3 years before randomization; 9. Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody; 10. Patient with severe infection within 4 weeks before enrollment, or unexplained fever\> 38.5℃ during screening/before enrollment; 11. Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment; 12. Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; symptomatic pulmonary embolism; 13. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug; 14. Patient with a known hypersensitivity to any of the excipients in this study; 15. A prior history of autologous or allogeneic hematopoietic stem cell transplantation; 16. A prior history of psychotropic drug abuse or drug use; 17. Pregnant or breastfeeding; 18. The researchers considered that there were some cases that were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed progression free survival (PFS) | Up to approximately 24 months | An interim analysis will be performed in this study. The primary endpoint of the study is PFS. An interim analysis is scheduled upon the collection of 70%(approximately 125) PFS events, and the final PFS analysis will be conducted after 178 PFS events have been collected. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to approximately 5 years |
| Disease control rate (DCR) | Up to approximately 24 months |
| Clinical benefit rate (CBR) | Up to approximately 24 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to approximately 24 months |
| Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0 | Up to approximately 24 months |
| Maximum Plasma Concentration [Cmax] | Up to approximately 4 months |
| Time to Maximum Plasma Concentration [Tmax] | Up to approximately 4 months |
| Area under the time-concentration Curve [AUC] | Up to approximately 4 months |
| BICR-assessed progression free survival (PFS) | Up to approximately 24 months |
| Overall survival rate(OSR) | Up to approximately 5 years |
| Objective response rate (ORR) | Up to approximately 24 months |
| Duration of response (DoR) | Up to approximately 24 months |
Other
| Measure | Time frame |
|---|---|
| EQ-5D-5L scale | Up to approximately 24 months |
| Plasma ctDNA | Up to approximately 5 months |
| EORTC QLQ-C30 scale | Up to approximately 24 months |
| EORTC QLQ-BR23 scale | Up to approximately 24 months |
Countries
China
Outcome results
None listed