NCT04903652 is a Phase 2 clinical trial of Pyrotinib Maleate in HER2-positive Advanced Breast Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital.

Who is sponsoring NCT04903652?

NCT04903652 is sponsored by Tianjin Medical University Cancer Institute and Hospital.

What drugs are being tested in NCT04903652?

Interventions in NCT04903652: Pyrotinib Maleate, Vinorelbine.

What condition does NCT04903652 study?

NCT04903652 studies HER2-positive Advanced Breast Cancer.

Is NCT04903652 still recruiting?

NCT04903652 is currently completed. Last updated 7 April 2022.

Last reviewed 2022-04-07 · How we verify

NCT04903652

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer

Completed Phase 2 Last updated 7 April 2022

What this trial tests

Phase 2 trial testing Pyrotinib Maleate in HER2-positive Advanced Breast Cancer in 30 participants. Completed in 6 February 2022.

Timeline

1 January 2021

Primary endpoint
1 February 2022

6 February 2022

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 January 2021
Primary completion	1 February 2022
Estimated completion	6 February 2022
Sites	1 location across China

Drugs / interventions tested

Pyrotinib Maleate
Vinorelbine (vinorelbine) — full drug profile →

Conditions studied

HER2-positive Advanced Breast Cancer — all drugs for HER2-positive Advanced Breast Cancer →

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 75, female only, with HER2-positive Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-center, single-arm, prospective phase II clinical study, which mainly evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the treatment of HER2-positive advanced breast cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study.
Hao C, Wang X, Shi Y, Tong Z, et al · · 2025 · cited 1× · PMID 39118524 · DOI 10.4143/crt.2024.340

Verify or expand the search:

Other trials of Pyrotinib Maleate

Trials testing the same drug.

NCT05328440 — Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02) · Phase 2 · unknown
NCT05274191 — An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors · Phase 2 · unknown
NCT04680091 — Drug-Drug Interaction of Pyrotinib With a Moderate CYP3A Inducer · Phase 1 · unknown
NCT03574402 — Phase II Umbrella Study Directed by Next Generation Sequencing · Phase 2 · unknown

Other recruiting trials for HER2-positive Advanced Breast Cancer

Currently open trials in the same condition.

NCT07100600 — Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced · Phase 2 · recruiting
NCT05856383 — Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC · recruiting

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04903652 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital
Last refreshed: 7 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04903652.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing