A Study of XZP-3287 in Combination With Fulvestrant 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 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05077449
• Other study ID #: XZP-3287-3001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 16, 2021
• Est. completion date: November 2029

Study information

• Verified date: May 2024
• Source: Xuanzhu Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 2029
• Est. primary completion date: February 22, 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. 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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• XZP-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 + Fulvestrant
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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Science	Beijing	Beijing

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	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
Other	Plasma ctDNA		Up to approximately 5 months
Primary	Investigator-assessed progression free survival (PFS)	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.	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