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Trial · NCT07892274

Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer

NCT07892274, Phase 3, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer. Trials, record NCT07892274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892274

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
NCT number
NCT07892274
Status
Not yet recruiting
Phases
Phase 3
Enrollment
226 participants, estimated
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
Interventions
Fulvestrant, Pyrotinib, Dalpiciclib, Trastuzumab Rezetecan
First posted
2026-10-23
Last updated
2026-10-23

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProgression-Free Survival (PFS)24 months
Time from randomization to first radiologically confirmed disease progression, treatment discontinuation due to intolerable toxicity without recorded progression, or death from any cause, whichever occurs first.
SecondaryOverall Survival (OS)36 monthsTime from randomization to death from any cause.
SecondaryObjective response rate (ORR)24 monthsAccording to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients.
SecondaryClinical Benefit Rate (CBR)24 monthsAccording to recist1.1 standard, the proportion of patients whose best remission was CR or PR or SD ≥ 24 weeks accounted for the total number of evaluable patients.
SecondaryFACT-B24 months
It includes physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns, comprehensively assessing patients' physical, psychological, and social functioning, as well as treatment-related symptoms such as hair loss and nausea.
SecondaryQLQ-BR2324 monthsIt comprises 23 items assessing quality of life, symptoms, functional status, and psychological experiences in patients with breast cancer.
SecondaryIncidence of adverse events(AE)from the date of enrollment to one yearIncidence of adverse events(AE)
SecondaryBiomarkers and treatment sensitivity analysis12 months
Cox univariate and multivariate analysis will be used to explore the correlation between endocrine and HER2 pathway related biomarkers and treatment sensitivity(The biomarkers to be analyzed included 324 tumor related genes included in the FoundationOne CDx, and ER/PR/HER2/ki67 in IHC)

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
19786670BACKGROUNDPubMed
28498781BACKGROUNDPubMed
31430226BACKGROUNDPubMed
31825192BACKGROUNDPubMed
35020204BACKGROUNDPubMed
36495879BACKGROUNDPubMed
37086745BACKGROUNDPubMed
39712455BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07892274

GET https://conductscience.org/api/trials/v1/NCT07892274/registered