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NCT05870579 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
20
Study locations

NCT05870579: Recruiting Phase 1 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.

NCT05870579 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 48 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05870579, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB, ribociclib and fulvestrant with or without goserelin. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Fulvestrant
  • DRUG Ribociclib
  • DRUG [68Ga]Ga-NeoB
  • DRUG [177Lu]Lu-NeoB
  • OTHER Goserelin

Study Locations (20)

Other

  • Novartis Investigative Site - Guangzhou
  • Novartis Investigative Site - Shanghai
  • Novartis Investigative Site - Tianjin
  • Novartis Investigative Site - Bordeaux
  • Novartis Investigative Site - Clermont-Ferrand
  • Novartis Investigative Site - Saint-Herblain
  • Novartis Investigative Site - Strasbourg
  • Novartis Investigative Site - Cologne
  • Novartis Investigative Site - Erlangen
  • Novartis Investigative Site - Essen
  • Novartis Investigative Site - München
  • Novartis Investigative Site - Gliwice
  • Novartis Investigative Site - Porto

California

  • UCLA Jonsson Comp Cancer Center - Los Angeles
  • Hoag Memorial Hospital Presbyterian - Newport Beach

Kansas

  • University of Kansas Medical Center - Westwood

Pennsylvania

  • University of Pennsylvania - Philadelphia

Texas

  • MD Anderson Cancer Center - Houston

Utah

  • Utah Intermountain Medical Center - Murray

Hauts De Seine

  • Novartis Investigative Site - Saint-Cloud

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2023-11-13
Est. Completion 2032-01-26
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What NCT05870579 shows while recruiting

NCT05870579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.

NCT05870579 names 20 study sites across 7 states, led by Other, California, Kansas.

Frequently Asked Questions

What is clinical trial NCT05870579 about?

NCT05870579 is a clinical study titled "[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer". 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 (G...

What is the current status of trial NCT05870579?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2023-11-13. Estimated completion is 2032-01-26.

What conditions does trial NCT05870579 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05870579?

The interventions under investigation include: Fulvestrant (DRUG), Ribociclib (DRUG), [68Ga]Ga-NeoB (DRUG), [177Lu]Lu-NeoB (DRUG), Goserelin (OTHER).

Who is sponsoring clinical trial NCT05870579?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05870579 being conducted?

This trial has 20 study locations across California, Kansas, Pennsylvania, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05870579's enrollment target sits among peer trials

48 821st of 1224 higher than 394 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05870579

Source: ClinicalTrials.gov NCT05870579, the US trial registry maintained by the National Library of Medicine. NCT05870579 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.