Who is sponsoring NCT03993964?

NCT03993964 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT03993964?

Interventions in NCT03993964: Pyrotinib combine with SHR6390.

What condition does NCT03993964 study?

NCT03993964 studies Metastatic Breast Cancer.

Is NCT03993964 still recruiting?

NCT03993964 is currently status unknown. Last updated 21 June 2019.

Last reviewed 2019-06-21 · How we verify

NCT03993964

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

Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer

Status unknown Phase 2 Last updated 21 June 2019

What this trial tests

Phase 2 trial testing Pyrotinib combine with SHR6390 in Metastatic Breast Cancer in 20 participants. Status unknown.

Timeline

15 August 2019

Primary endpoint
30 October 2020

15 April 2021

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	15 August 2019
Primary completion	30 October 2020
Estimated completion	15 April 2021

Drugs / interventions tested

Pyrotinib combine with SHR6390 — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The Roles of Cyclin-Dependent Kinases in Cell-Cycle Progression and Therapeutic Strategies in Human Breast Cancer.
Ding L, Cao J, Lin W, Chen H, et al · · 2020 · cited 385× · PMID 32183020 · DOI 10.3390/ijms21061960
CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
Mechanism, safety and efficacy of three tyrosine kinase inhibitors lapatinib, neratinib and pyrotinib in HER2-positive breast cancer.
Xuhong JC, Qi XW, Zhang Y, Jiang J. · · 2019 · cited 118× · PMID 31720077
The evolution of cyclin dependent kinase inhibitors in the treatment of cancer.
Jhaveri K, Burris Rd HA, Yap TA, Hamilton E, et al · · 2021 · cited 40× · PMID 34176404 · DOI 10.1080/14737140.2021.1944109
Novel and Alternative Targets Against Breast Cancer Stemness to Combat Chemoresistance.
Sridharan S, Howard CM, Tilley AMC, Subramaniyan B, et al · · 2019 · cited 37× · PMID 31681564 · DOI 10.3389/fonc.2019.01003
New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?pi.
Mezni E, Vicier C, Guerin M, Sabatier R, et al · · 2020 · cited 22× · PMID 32545895 · DOI 10.3390/cancers12061573
Tyrosine Kinase Inhibitors in the Combination Therapy of HER2 Positive Breast Cancer.
Yang X, Wu D, Yuan S. · · 2020 · cited 13× · PMID 33034269 · DOI 10.1177/1533033820962140
A narrative review about CDK4/6 inhibitors in the setting of drug resistance: updates on biomarkers and therapeutic strategies in breast cancer.
Zhao S, Zhang H, Yang N, Yang J. · · 2023 · cited 12× · PMID 37434680 · DOI 10.21037/tcr-22-2807

Verify or expand the search:

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet 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 NCT03993964 (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 Sun Yat-sen University
Last refreshed: 21 June 2019

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/NCT03993964.

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