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

Last updated: April 18, 2025
Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Placebo + Letrozole/Anastrozole

XZP-3287+ Letrozole/Anastrozole

Clinical Study ID

NCT05257395
XZP-3287-3002
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 metastaticbreast cancer, which was pathologically confirmed to be HR-positive andHER2-negative;

  4. Evidence of locally advanced, recurrent, or metastatic disease that is not amenableto curative surgical resection or radiation therapy and is not clinically amenableto chemotherapy;

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

  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 beforerandomization, and the result is negative; patient is willing to use a medicallyapproved high-efficiency contraceptive method during the study period and within 6months after the last study drug treatment;

  10. Patient with acute toxic reactions caused by previous anti-tumor treatments orsurgical operations were alleviated to grade 0 to 1 (NCI-CTCAE v5.0), or to thelevel specified by the enrollment criteria;

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

Exclusion

Exclusion Criteria:

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

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

  3. Patient had clinically significant pleural effusions, ascites effusions, orpericardial 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, andany anti-tumor treatment within 14 days before enrollment;

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

  7. Patient used CYP3A4 potent inhibitors or potent inducers within 14 days beforeenrollment 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 notchange 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 Patientwith positive HIV antibody;

  11. Patient with severe infection within 4 weeks before enrollment, or unexplainedfever> 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, includinghistory of transient ischemic attack or stroke; pulmonary embolism;

  14. Inability to swallow, intestinal obstruction or other factors that affect the takingand 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 forinclusion.

Study Design

Total Participants: 397
Treatment Group(s): 2
Primary Treatment: Placebo + Letrozole/Anastrozole
Phase: 3
Study Start date:
March 14, 2022
Estimated Completion Date:
September 05, 2030

Connect with a study center

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

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