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

NCT05257395 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: XZP-3287-3002
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer

Keywords

XZP-3287; HR positive Her2 negative recurrent/metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed progression free survival (PFS)

  Up to approximately 24 months

Secondary Outcomes (12)

• BICR-assessed progression free survival (PFS)

  Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 5 years

• Overall survival rate(OSR)

  Up to approximately 5 years

• Objective response rate (ORR)

  Up to approximately 24 months

• Duration of response (DoR)

  Up to approximately 24 months

Other Outcomes (4)

• Time to Deterioration（TTD）

  Up to approximately 24 months

• EORTC QLQ-C30 scale

  Up to approximately 24 months

• EORTC QLQ-BR23 scale

  Up to approximately 24 months

Study Arms (2)

XZP-3287+ Letrozole/Anastrozole

EXPERIMENTAL

Drug: XZP-3287+ Letrozole/Anastrozole

Placebo + Letrozole/Anastrozole

PLACEBO COMPARATOR

Drug: Placebo + Letrozole/Anastrozole

Interventions

XZP-3287+ Letrozole/Anastrozole DRUG

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

XZP-3287+ Letrozole/Anastrozole

Placebo + Letrozole/Anastrozole DRUG

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

Placebo + Letrozole/Anastrozole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Qingyuan Zhang

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: March 14, 2022
• Primary Completion: December 5, 2025
• Study Completion (Estimated): September 5, 2030
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)