A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
Primary Purpose
Advanced Breast Cancer
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
XZP-3287+ Letrozole/Anastrozole
Placebo + Letrozole/Anastrozole
Sponsored by

About this trial
This is an interventional treatment trial for Advanced Breast Cancer focused on measuring XZP-3287, HR positive Her2 negative recurrent/metastatic breast cancer
Eligibility Criteria
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.
Sites / Locations
- Harbin Medical University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XZP-3287+ Letrozole/Anastrozole
Placebo + Letrozole/Anastrozole
Arm Description
Outcomes
Primary Outcome Measures
Investigator-assessed progression free survival (PFS)
Secondary Outcome Measures
BICR-assessed progression free survival (PFS)
Overall survival (OS)
Overall survival rate(OSR)
Objective response rate (ORR)
Duration of response (DoR)
Disease control rate (DCR)
Clinical benefit rate (CBR)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Maximum Plasma Concentration [Cmax]
Time to Maximum Plasma Concentration [Tmax]
Area under the time-concentration Curve [AUC]
Full Information
NCT ID
NCT05257395
First Posted
February 16, 2022
Last Updated
February 16, 2022
Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05257395
Brief Title
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
Keywords
XZP-3287, HR positive Her2 negative recurrent/metastatic breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
372 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XZP-3287+ Letrozole/Anastrozole
Arm Type
Experimental
Arm Title
Placebo + Letrozole/Anastrozole
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
XZP-3287+ Letrozole/Anastrozole
Intervention Description
XZP-3287 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Placebo + Letrozole/Anastrozole
Intervention Description
Placebo 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle
Primary Outcome Measure Information:
Title
Investigator-assessed progression free survival (PFS)
Time Frame
Up to approximately 24 months
Secondary Outcome Measure Information:
Title
BICR-assessed progression free survival (PFS)
Time Frame
Up to approximately 24 months
Title
Overall survival (OS)
Time Frame
Up to approximately 5 years
Title
Overall survival rate(OSR)
Time Frame
Up to approximately 5 years
Title
Objective response rate (ORR)
Time Frame
Up to approximately 24 months
Title
Duration of response (DoR)
Time Frame
Up to approximately 24 months
Title
Disease control rate (DCR)
Time Frame
Up to approximately 24 months
Title
Clinical benefit rate (CBR)
Time Frame
Up to approximately 24 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
Up to approximately 24 months
Title
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Time Frame
Up to approximately 24 months
Title
Maximum Plasma Concentration [Cmax]
Time Frame
Up to approximately 4 months
Title
Time to Maximum Plasma Concentration [Tmax]
Time Frame
Up to approximately 4 months
Title
Area under the time-concentration Curve [AUC]
Time Frame
Up to approximately 4 months
Other Pre-specified Outcome Measures:
Title
Time to Deterioration(TTD)
Description
Time from randomization to the first worsening of the EORTC QLQ-C30 scale score.
Time Frame
Up to approximately 24 months
Title
EORTC QLQ-C30 scale
Time Frame
Up to approximately 24 months
Title
EORTC QLQ-BR23 scale
Time Frame
Up to approximately 24 months
Title
EQ-5D-5L scale
Time Frame
Up to approximately 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuilan Xiao
Phone
(+86)13699167610
Email
xiaocuilan@xuanzhubio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Organizational Affiliation
Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Phone
(+86)13313612989
Email
13313612989@163.com
12. IPD Sharing Statement
Learn more about this trial
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
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