Status:
ACTIVE_NOT_RECRUITING
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
Lead Sponsor:
Xuanzhu Biopharmaceutical Co., Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2030
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT05257395
Start Date
March 14 2022
End Date
September 5 2030
Last Update
July 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081