A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

NCT ID: NCT05077449

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2029-11-30

Brief 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.

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XZP-3287+Fulvestrant

Group Type: EXPERIMENTAL

XZP-3287+Fulvestrant

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo + Fulvestrant

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xuanzhu Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binghe Xu

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

XZP-3287-3001

Identifier Type: -

Identifier Source: org_study_id