Who is sponsoring NCT03608865?

NCT03608865 is sponsored by Yonsei University.

What drugs are being tested in NCT03608865?

Interventions in NCT03608865: Durvalumab with Tremelimumab.

What condition does NCT03608865 study?

NCT03608865 studies Metastatic Breast Cancer.

Is NCT03608865 still recruiting?

NCT03608865 is currently completed. Last updated 3 January 2022.

Last reviewed 2022-01-03 · How we verify

NCT03608865

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

Durvalumab (MEDI4736) and Tremelimumab in Hormone Receptor-positive, Hypermutated Metastatic Breast Cancer Identified by Whole Exome Sequencing

Completed Phase 2 Last updated 3 January 2022

What this trial tests

Phase 2 trial testing Durvalumab with Tremelimumab in Metastatic Breast Cancer in 30 participants. Completed in 24 November 2021.

Timeline

19 September 2017

Primary endpoint
24 November 2021

24 November 2021

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	19 September 2017
Primary completion	24 November 2021
Estimated completion	24 November 2021
Sites	1 location across South Korea

Drugs / interventions tested

Durvalumab with Tremelimumab — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Yonsei University

Who can join

19 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Abbreviated Title : Durvalumab + tremelimumab in hypermutated breast cancer Trial Phase : II Clinical Indication : Hormone receptor-positive metastatic breast cancer Trial Type : Interventional Type of control : None Route of administration : Intravenous Trial Blinding : None Treatment Groups : Durvalumab + tremelimumab Number of trial subjects : Approximately 150 patients will be prescreened with whole exome sequencing. Then 30 patients will be enrolled in the treatment phase. Estimated enrollment period : 24 months Estimated duration of trial : The sponsor estimates that the trial will require approximately 48 months from the time the first subject signs the informed consent until the last subject's last visit. Duration of Participation : 24 months Estimated average length of treatment per patient : 8 months

Publications & conference data

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

An Overview of Antibody Conjugated Polymeric Nanoparticles for Breast Cancer Therapy.
Juan A, Cimas FJ, Bravo I, Pandiella A, et al · · 2020 · cited 68× · PMID 32854255 · DOI 10.3390/pharmaceutics12090802
Luminal Breast Cancer: Risk of Recurrence and Tumor-Associated Immune Suppression.
Pellegrino B, Hlavata Z, Migali C, De Silva P, et al · · 2021 · cited 52× · PMID 33974235 · DOI 10.1007/s40291-021-00525-7
Biomarker predictors for immunotherapy benefit in breast: beyond PD-L1.
James JL, Balko JM. · · 2019 · cited 9× · PMID 33312343 · DOI 10.1007/s12609-019-00331-5
Unlocking the Potential of Immune Checkpoint Inhibitors in HR+/HER2- Breast Cancer: A Systematic Review.
Di Grazia G, Dri A, Grieco A, Martinelli C, et al · · 2025 · cited 1× · PMID 40941037 · DOI 10.3390/cancers17172940

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 Yonsei University trials

Trials by the same sponsor.

NCT07547592 — Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma · Phase 2 · not yet recruiting
NCT07524101 — Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD · NA · not yet recruiting
NCT07506629 — Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty · NA · not yet recruiting
NCT07515716 — Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
NCT07507188 — Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients · Phase 2 · 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 NCT03608865 (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 Yonsei University
Last refreshed: 3 January 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/NCT03608865.

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