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NCT07459738
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Phase 2 trial testing HLX43 in Hormone Receptor Positive HER-2 Negative Breast Cancer in 60 participants. Not yet recruiting.
30 December 2026
Quick facts
| Lead sponsor | Shanghai Henlius Biotech |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 April 2026 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2027 |
Drugs / interventions tested
- HLX43
Conditions studied
- Hormone Receptor Positive HER-2 Negative Breast Cancer — all drugs for Hormone Receptor Positive HER-2 Negative Breast Cancer →
Sponsor
Shanghai Henlius Biotech — full company profile →
Who can join
Adults 18 to 75, any sex, with Hormone Receptor Positive HER-2 Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07459738
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HLX43
Trials testing the same drug.
- NCT07459751 — A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination Wi · Phase 2, PHASE3 · not yet recruiting
- NCT06115642 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors · Phase 1 · recruiting
Other recruiting trials for Hormone Receptor Positive HER-2 Negative Breast Cancer
Currently open trials in the same condition.
- NCT06201234 — Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+ · Phase 2 · recruiting
- NCT06369285 — A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Meta · Phase 2 · recruiting
- NCT06805812 — Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormon · recruiting
- NCT05608252 — VS-6766+Abema+Fulv in Met HR+/HER- BC · Phase 1, PHASE2 · recruiting
Other Shanghai Henlius Biotech trials
Trials by the same sponsor.
- NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
- NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
- NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
- NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
- NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT07459738 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Henlius Biotech
- Last refreshed: 10 March 2026
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/NCT07459738.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing