NCT05257395Active, not recruitingPhase 3
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Xuanzhu Biopharmaceutical Co., Ltd.1 site in 1 country397 target enrollmentStarted: March 14, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 397
- Locations
- 1
- Primary Endpoint
- Investigator-assessed progression free survival (PFS)
Study Overview
Brief Summary
This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged ≥18 years and ≤75 years old;
- •Patient is in the menopausal state；
- •Histologically or cytologically confirmed locally advanced, recurrent or metastatic breast cancer, which was pathologically confirmed to be HR-positive and HER2-negative;
- •Evidence of locally advanced, recurrent, or metastatic disease that is not amenable to curative surgical resection or radiation therapy and is not clinically amenable to chemotherapy;
- •No prior systemic anticancer therapy for locally advanced, recurrent, or metastatic disease;
- •At least one measurable lesion (based on RECIST v1.1) or only bone metastases;
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Adequate organ and marrow function;
- •Patient of childbearing age must undergo a serum pregnancy test within 7 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;
- •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;
- •Patient has signed informed consent before any trial related activities.
Exclusion Criteria
- •Patients with disease recurrence or metastasis at or within 12 months after previous neoadjuvant or adjuvant therapy with endocrine drugs;
- •Patient with visceral crisis or brain metastases, except for patient with stable brain metastases;
- •Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;
- •Patient who received prior treatment with mTOR inhibitors or CDK4/6 inhibitors ;
- •Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment；
- •Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer;
- •Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;
- •Initiation of bisphosphonates or RANKL inhibitors within 7 days before enrollment, and subjects who have initiated treatment > 7 days before enrollment should not change the method of use;
- •Any other malignant tumor has been diagnosed within 5 years before randomization;
- •Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody;
- •Patient with severe infection within 4 weeks before enrollment, or unexplained fever> 38.3℃ during screening/before enrollment;
- •Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment;
- •Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; pulmonary embolism;
- •Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug;
- •Patient with a known hypersensitivity to any of the excipients in this study;
- •A prior history of autologous or allogeneic hematopoietic stem cell transplantation;
- •A prior history of psychotropic drug abuse or drug use;
- •Nursing Mothers;
- •The researchers considered that there were some cases that were not suitable for inclusion.
Arms & Interventions
XZP-3287+ Letrozole/Anastrozole
Experimental
Intervention: XZP-3287+ Letrozole/Anastrozole (Drug)
Placebo + Letrozole/Anastrozole
Placebo Comparator
Intervention: Placebo + Letrozole/Anastrozole (Drug)
Outcomes
Primary Outcomes
Investigator-assessed progression free survival (PFS)
Time Frame: Up to approximately 24 months
Secondary Outcomes
- Overall survival (OS)(Up to approximately 5 years)
- Overall survival rate(OSR)(Up to approximately 5 years)
- BICR-assessed progression free survival (PFS)(Up to approximately 24 months)
- Clinical benefit rate (CBR)(Up to approximately 24 months)
- Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to approximately 24 months)
- Time to Maximum Plasma Concentration [Tmax](Up to approximately 4 months)
- Area under the time-concentration Curve [AUC](Up to approximately 4 months)
- Objective response rate (ORR)(Up to approximately 24 months)
- Duration of response (DoR)(Up to approximately 24 months)
- Maximum Plasma Concentration [Cmax](Up to approximately 4 months)
Investigators
Study Sites (1)
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