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Trials
A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer

trialsTrialRecruiting

A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer

A phase 3 trial of Capecitabine and Lapatinib in advanced solid tumours, run by Tianjin Hemay Pharmaceutical Co., Ltd, now recruiting.

Overview Connected3

Overview

A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer is a phase 3 interventional study registered as NCT06313983 by Tianjin Hemay Pharmaceutical Co., Ltd, with 339 participants planned, started 2022-01-08 and due to reach its primary completion in 2025-12. Interventions recorded: Hemay022+AI and Lapatinib+Capecitabine.

Setting

A Phase Ⅲ Randomized, Open Label, Parallel, Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2+/ER+ Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens

Phase

Phase 3

Sponsor

Tianjin Hemay Pharmaceutical Co., Ltd

Registry

Started

2022-01-08

Enrolled

339 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

ApprovedSmall-molecule reversible HER2/EGFR kinase inhibitor

Lapatinib · Tykerb

Evidence strength48/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
339 enrolled+13
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-16 · Jude Gomila · Registry trials wave 6 and products wave 7 · diff · file

Sources & links

ClinicalTrials.gov NCT06313983

Data

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