NCT05870579 is a Phase 1 clinical trial of [68Ga]Ga-NeoB in Breast Cancer, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT05870579?

NCT05870579 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT05870579?

Interventions in NCT05870579: [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib, Fulvestrant, Goserelin.

What condition does NCT05870579 study?

NCT05870579 studies Breast Cancer.

Is NCT05870579 still recruiting?

NCT05870579 is currently recruiting now. Last updated 21 August 2025.

Last reviewed 2025-08-21 · How we verify

NCT05870579

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

[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer

Recruiting now Phase 1 Last updated 21 August 2025

What this trial tests

Phase 1 trial testing [68Ga]Ga-NeoB in Breast Cancer in 48 participants. Currently enrolling.

Timeline

13 November 2023

Primary endpoint
30 December 2026

26 January 2032

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	13 November 2023
Primary completion	30 December 2026
Estimated completion	26 January 2032
Sites	25 locations across France, Germany, Poland, China, Spain, United States, Portugal

Drugs / interventions tested

[68Ga]Ga-NeoB
[177Lu]Lu-NeoB
Ribociclib (ribociclib) — full drug profile →
Fulvestrant (fulvestrant) — full drug profile →
Goserelin (goserelin) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this trial is to estimate the recommended dose (RD) of \[177Lu\]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) advanced breast cancer experiencing early relapse from (neo)adjuvant endocrine therapy or who have progressed on endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease.

Publications & conference data

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

Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets.
Taunk NK, Escorcia FE, Lewis JS, Bodei L. · · 2024 · cited 8× · PMID 38753757 · DOI 10.1097/ppo.0000000000000720
Targeted radionuclide therapy for patients with central nervous system metastasis: Overlooked potential?
Le Rhun E, Albert NL, Hüllner M, Franceschi E, et al · · 2024 · cited 7× · PMID 39351771 · DOI 10.1093/neuonc/noae192
Emerging PET Imaging Agents and Targeted Radioligand Therapy: A Review of Clinical Applications and Trials.
Palihati M, Das JP, Yeh R, Capaccione K. · · 2025 · cited 5× · PMID 40863874 · DOI 10.3390/tomography11080083
Chemotherapy alters radiosensitivity and GRPR expression of prostate and breast cancer cells.
Damiana TST, van den Brink L, de Kreij-de Bruin LW, Stuurman DC, et al · · 2025 · cited 1× · PMID 40751101 · DOI 10.1186/s13550-025-01302-x
Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention.
Lei H, Fu J, Gu W, Qiao H, et al · · 2026 · PMID 41510186 · DOI 10.1002/mco2.70560
Alternate actions of CDK4/6 inhibitors beyond cell cycle blockade: unexplored roles in therapy resistance.
Scordamaglia D, Talia M, Zicarelli A, Mondino AA, et al · · 2025 · PMID 41388212 · DOI 10.1007/s10555-025-10307-w
Current Approaches of Nuclear Molecular Imaging in Breast Cancer.
Schäfer L, Altunay B, Heesch A, van Nijnatten T, et al · · 2025 · PMID 40647404 · DOI 10.3390/cancers17132105

Verify or expand the search:

Other trials of [68Ga]Ga-NeoB

Trials testing the same drug.

NCT06247995 — A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GR · Phase 1, PHASE2 · recruiting
NCT06379217 — NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastati · Phase 1 · active not recruiting
NCT05739942 — Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma · Phase 1 · active not recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · 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 NCT05870579 (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 Novartis Pharmaceuticals
Last refreshed: 21 August 2025

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/NCT05870579.

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