A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05257395
• Other study ID #: XZP-3287-3002
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: Xuanzhu Biopharmaceutical Co., Ltd.
• Contact: Cuilan Xiao
• Phone: (+86)13699167610
• Email: xiaocuilan[@]xuanzhubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 372
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female patients aged =18 years and =75 years old;

2. Patient is in the menopausal state;

3. Histologically or cytologically confirmed locally advanced, recurrent or metastatic breast cancer, which was pathologically confirmed to be HR-positive and HER2-negative;

4. 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;

5. No prior systemic anticancer therapy for locally advanced, recurrent, or metastatic disease;

6. At least one measurable lesion (based on RECIST v1.1) or only bone metastases;

7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;

8. Adequate organ and marrow function;

9. 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;

10. 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;

11. Patient has signed informed consent before any trial related activities.

Exclusion Criteria:

1. Patients with disease recurrence or metastasis at or within 12 months after previous neoadjuvant or adjuvant therapy with endocrine drugs;

2. Patient with visceral crisis or brain metastases, except for patient with stable brain metastases;

3. Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;

4. Patient who received prior treatment with mTOR inhibitors or CDK4/6 inhibitors ;

5. Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment;

6. Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer;

7. Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;

8. 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;

9. Any other malignant tumor has been diagnosed within 5 years before randomization;

10. Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody;

11. Patient with severe infection within 4 weeks before enrollment, or unexplained fever> 38.3? during screening/before enrollment;

12. Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment;

13. Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; pulmonary embolism;

14. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug;

15. Patient with a known hypersensitivity to any of the excipients in this study;

16. A prior history of autologous or allogeneic hematopoietic stem cell transplantation;

17. A prior history of psychotropic drug abuse or drug use;

18. Nursing Mothers;

19. The researchers considered that there were some cases that were not suitable for inclusion.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• XZP-3287+ Letrozole/Anastrozole
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
• Placebo + Letrozole/Anastrozole
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

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xuanzhu Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Deterioration(TTD)	Time from randomization to the first worsening of the EORTC QLQ-C30 scale score.	Up to approximately 24 months
Other	EORTC QLQ-C30 scale		Up to approximately 24 months
Other	EORTC QLQ-BR23 scale		Up to approximately 24 months
Other	EQ-5D-5L scale		Up to approximately 24 months
Primary	Investigator-assessed progression free survival (PFS)		Up to approximately 24 months
Secondary	BICR-assessed progression free survival (PFS)		Up to approximately 24 months
Secondary	Overall survival (OS)		Up to approximately 5 years
Secondary	Overall survival rate(OSR)		Up to approximately 5 years
Secondary	Objective response rate (ORR)		Up to approximately 24 months
Secondary	Duration of response (DoR)		Up to approximately 24 months
Secondary	Disease control rate (DCR)		Up to approximately 24 months
Secondary	Clinical benefit rate (CBR)		Up to approximately 24 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0		Up to approximately 24 months
Secondary	Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0		Up to approximately 24 months
Secondary	Maximum Plasma Concentration [Cmax]		Up to approximately 4 months
Secondary	Time to Maximum Plasma Concentration [Tmax]		Up to approximately 4 months
Secondary	Area under the time-concentration Curve [AUC]		Up to approximately 4 months