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

NCT05077449 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: XZP-3287-3001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 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)

• EORTC QLQ-C30 scale

  Up to approximately 24 months

• EORTC QLQ-BR23 scale

  Up to approximately 24 months

• EQ-5D-5L scale

  Up to approximately 24 months

Study Arms (2)

XZP-3287+Fulvestrant

EXPERIMENTAL

Drug: XZP-3287+Fulvestrant

Placebo + Fulvestrant

PLACEBO COMPARATOR

Drug: Placebo + Fulvestrant

Interventions

XZP-3287+Fulvestrant 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

XZP-3287+Fulvestrant

Placebo + Fulvestrant 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

Placebo + Fulvestrant

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；
• Pathologically-confirmed HR positive and Her2 negative Breast Cancer;
• 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;
• 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 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;
• 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:

• Patient with visceral crisis, inflammatory breast cancer, 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, CDK4/6 inhibitors or fulvestrant;
• 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;
• 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;
• Any other malignant tumor has been diagnosed within 3 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\> 38.5℃ 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; symptomatic 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;
• A prior history of autologous or allogeneic hematopoietic stem cell transplantation;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100025, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Binghe Xu

  Chinese Academy of Medical Sciences

  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: September 18, 2021
• First Posted: October 14, 2021
• Study Start: November 16, 2021
• Primary Completion: February 22, 2024
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

CN (1)