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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 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.

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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.

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

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT05870579

The ClinicalTrials.gov registry entry for NCT05870579 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.