NCT03596658 is a Phase 1 clinical trial of SHR9549 in ER+ HER2- Advanced Breast Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd..

Who is sponsoring NCT03596658?

NCT03596658 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT03596658?

Interventions in NCT03596658: SHR9549.

What condition does NCT03596658 study?

NCT03596658 studies ER+ HER2- Advanced Breast Cancer.

Is NCT03596658 still recruiting?

NCT03596658 is currently terminated. Last updated 1 September 2022.

Last reviewed 2022-09-01 · How we verify

NCT03596658

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

SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

Terminated Phase 1 Last updated 1 September 2022

What this trial tests

Phase 1 trial testing SHR9549 in ER+ HER2- Advanced Breast Cancer in 4 participants. Terminated before completion.

Timeline

25 July 2018

Primary endpoint
14 October 2019

14 October 2019

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	25 July 2018
Primary completion	14 October 2019
Estimated completion	14 October 2019
Sites	1 location across China

Drugs / interventions tested

SHR9549 — full drug profile →

Conditions studied

ER+ HER2- Advanced Breast Cancer — all drugs for ER+ HER2- Advanced Breast Cancer →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, female only, with ER+ HER2- Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.

Publications & conference data

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

Overcoming Endocrine Resistance in Breast Cancer.
Hanker AB, Sudhan DR, Arteaga CL. · · 2020 · cited 686× · PMID 32289273 · DOI 10.1016/j.ccell.2020.03.009
The race to develop oral SERDs and other novel estrogen receptor inhibitors: recent clinical trial results and impact on treatment options.
Wang Y, Tang SC. · · 2022 · cited 50× · PMID 36229710 · DOI 10.1007/s10555-022-10066-y
Next-Generation Endocrine Therapies for Breast Cancer.
McDonnell DP, Wardell SE, Chang CY, Norris JD. · · 2021 · cited 35× · PMID 33705209 · DOI 10.1200/jco.20.03565
New generation estrogen receptor-targeted agents in breast cancer: present situation and future prospectives.
Min J, Liu X, Peng R, Chen CC, et al · · 2024 · cited 16× · PMID 39373009 · DOI 10.15212/amm-2024-0006
Fulvestrant as a reference antiestrogen and estrogen receptor (ER) degrader in preclinical studies: treatment dosage, efficacy, and implications on development of new ER-targeting agents.
Wang G. · · 2020 · cited 12× · PMID 32968620 · DOI 10.21037/tcr-20-2166

Verify or expand the search:

Other recruiting trials for ER+ HER2- Advanced Breast Cancer

Currently open trials in the same condition.

NCT06188520 — A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Com · Phase 1, PHASE2 · recruiting
NCT03616587 — Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. · Phase 1 · active not recruiting

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed

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 NCT03596658 (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 Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 1 September 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/NCT03596658.

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