CLINICAL_TRIALS ClinicalTrials.gov record update

An Open-Label, Multicenter Clinical Study of Trastuzumab Rezetecan Followed by Pyrotinib in Combination With Fulvestrant and Dalpiciclib in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT07892274
Title field or adapter rule: {'original_value': 'An Open-Label, Multicenter Clinical Study of Trastuzumab Rezetecan Followed by Pyrotinib in Combination With Fulvestrant and Dalpiciclib in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:30.356283+00:00
Published At: 2026-10-23T00:00:00+00:00
Record Updated At: 2026-10-23
Source Retrieved At: 2026-10-31T22:18:24.976182+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Metastatic Breast Cancer (MBC)", "HER2-Positive Breast Cancer", "Hormone Receptor-Positive Breast Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-23", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT07892274"
protocolSection.identificationModule.officialTitle: "An Open-Label, Multicenter Clinical Study of Trastuzumab Rezetecan Followed by Pyrotinib in Combination With Fulvestrant and Dalpiciclib in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer"
protocolSection.statusModule.overallStatus: "NOT_YET_RECRUITING"
protocolSection.designModule.phases: ["PHASE3"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['Fulvestrant + Pyrotinib + Dalpiciclib'], 'description': 'Selective estrogen receptor downregulator (SERD) with no agonist activity. Binds to and degrades the estrogen receptor, inhibiting estrogen signaling in HR-positive breast cancer cells. Supplied as a 250 mg/5 mL injection and administered intramuscularly. In this trial, a loading dose of 500 mg (two 250 mg/5 mL injections) is given on Days 0, 14, and 28, followed by 500 mg once monthly thereafter. Given in combination with pyrotinib and dalpiciclib in the experimental arm.', 'name': 'Fulvestrant', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Fulvestrant + Pyrotinib + Dalpiciclib'], 'description': 'Oral, irreversible pan-HER tyrosine kinase inhibitor that covalently binds the intracellular kinase domains of EGFR (HER1), HER2, and HER4, blocking downstream signaling and inhibiting tumor cell growth. Supplied as 80 mg tablets and administered orally at 400 mg (five 80 mg tablets) once daily, continuously. Given in combination with fulvestrant and dalpiciclib in the experimental arm.', 'name': 'Pyrotinib', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Fulvestrant + Pyrotinib + Dalpiciclib'], 'description': 'Oral, highly selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks CDK4/6-mediated phosphorylation of retinoblastoma protein, arresting cell-cycle progression and inhibiting tumor cell proliferation. Supplied as 125 mg tablets and administered orally at 125 mg (one 125 mg tablet) once daily for 21 consecutive days followed by 7 days of. Given in combination with pyrotinib and fulvestrant in the experimental arm.', 'name': 'Dalpiciclib', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Trastuzumab Rezetecan'], 'description': 'HER2-directed antibody-drug conjugate (ADC) composed of a humanized anti-HER2 IgG1 monoclonal antibody (trastuzumab) conjugated via a cleavable tetrapeptide-based linker to a topoisomerase I inhibitor payload (rezetecan, an exatecan derivative; also known as SHR169265), with a drug-to-antibody ratio of approximately 6. After binding to HER2 on tumor cells, the conjugate is internalized and the linker is cleaved in lysosomes, releasing the payload, which stabilizes topoisomerase I-DNA complexes and induces DNA double-strand breaks and apoptosis. Administered intravenously at 4.8 mg/kg once every 3 weeks (21-day cycle). In this trial, given as 6 cycles of induction before randomization, and continued as the control regimen after randomization for participants not switched to the experimental triplet.', 'name': 'Trastuzumab Rezetecan', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

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