Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-31 @ 5:50 AM
Study NCT ID:
NCT05257395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Deterioration（TTD）', 'timeFrame': 'Up to approximately 24 months', 'description': 'Time from randomization to the first worsening of the EORTC QLQ-C30 scale score.'}, {'measure': 'EORTC QLQ-C30 scale', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'EORTC QLQ-BR23 scale', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'EQ-5D-5L scale', 'timeFrame': 'Up to approximately 24 months'}], 'primaryOutcomes': [{'measure': 'Investigator-assessed progression free survival (PFS)', 'timeFrame': 'Up to approximately 24 months'}], 'secondaryOutcomes': [{'measure': 'BICR-assessed progression free survival (PFS)', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Overall survival rate(OSR)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Maximum Plasma Concentration [Cmax]', 'timeFrame': 'Up to approximately 4 months'}, {'measure': 'Time to Maximum Plasma Concentration [Tmax]', 'timeFrame': 'Up to approximately 4 months'}, {'measure': 'Area under the time-concentration Curve [AUC]', 'timeFrame': 'Up to approximately 4 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['XZP-3287', 'HR positive Her2 negative recurrent/metastatic breast cancer'], 'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤75 years old;\n2. Patient is in the menopausal state；\n3. Histologically or cytologically confirmed locally advanced, recurrent or metastatic breast cancer, which was pathologically confirmed to be HR-positive and HER2-negative;\n4. 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;\n5. No prior systemic anticancer therapy for locally advanced, recurrent, or metastatic disease;\n6. At least one measurable lesion (based on RECIST v1.1) or only bone metastases;\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n8. Adequate organ and marrow function;\n9. 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;\n10. 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;\n11. Patient has signed informed consent before any trial related activities.\n\nExclusion Criteria:\n\n1. Patients with disease recurrence or metastasis at or within 12 months after previous neoadjuvant or adjuvant therapy with endocrine drugs;\n2. Patient with visceral crisis or brain metastases, except for patient with stable brain metastases;\n3. Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;\n4. Patient who received prior treatment with mTOR inhibitors or CDK4/6 inhibitors ;\n5. Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment；\n6. Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer;\n7. Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;\n8. 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;\n9. Any other malignant tumor has been diagnosed within 5 years before randomization;\n10. Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody;\n11. Patient with severe infection within 4 weeks before enrollment, or unexplained fever\\> 38.3℃ during screening/before enrollment;\n12. Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment;\n13. Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; pulmonary embolism;\n14. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug;\n15. Patient with a known hypersensitivity to any of the excipients in this study;\n16. A prior history of autologous or allogeneic hematopoietic stem cell transplantation;\n17. A prior history of psychotropic drug abuse or drug use;\n18. Nursing Mothers;\n19. The researchers considered that there were some cases that were not suitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT05257395', 'briefTitle': 'A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xuanzhu Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'XZP-3287-3002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XZP-3287+ Letrozole/Anastrozole', 'interventionNames': ['Drug: XZP-3287+ Letrozole/Anastrozole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Letrozole/Anastrozole', 'interventionNames': ['Drug: Placebo + Letrozole/Anastrozole']}], 'interventions': [{'name': 'XZP-3287+ Letrozole/Anastrozole', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['XZP-3287+ Letrozole/Anastrozole']}, {'name': 'Placebo + Letrozole/Anastrozole', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Placebo + Letrozole/Anastrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'overallOfficials': [{'name': 'Qingyuan Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Harbin Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data supporting the findings of this trial, including source data, cannot be made available openly owing to their proprietary nature and that the BRIGHT-3 study is still ongoing and blinded.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanzhu Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}