Trial · NCT05870579
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
NCT05870579, Phase 1, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer. Trials, record NCT05870579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05870579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
- NCT number
- NCT05870579
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Breast Cancer
- Interventions
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib, Fulvestrant, Goserelin
- First posted
- 2023-05-23
- Last updated
- 2026-09-11
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and nature of DLTs during the DLT observation period | 28 days after the first administration of [177Lu]Lu-NeoB | 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. |
| Primary | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months | The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. |
| Primary | Incidence of dose interruptions, discontinuation and dose reductions | From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months | Dose interruptions, discontinuation and dose reductions will be assessed for tolerability. |
| Secondary | Time activity curves (TACs) of [177Lu]Lu-NeoB in organs and tumor lesions | Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 4 weeks) | Time activity curves (TACs) for the various organs and lesions will be produced as percentage of injected dose in selected organs and lesions. |
| Secondary | Absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions | Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 4 weeks) | The absorbed dose in target organs will be summarized with descriptive statistics. |
| Secondary | Concentration of [177Lu]Lu-NeoB in blood over time | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Blood concentration of \[177Lu\]Lu-NeoB will be summarized with descriptive statistics. |
| Secondary | Observed maximum blood concentration (Cmax) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Cmax will be listed and summarized using descriptive statistics. |
| Secondary | Time of maximum observed drug concentration occurrence (Tmax) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Tmax will be listed and summarized using descriptive statistics. |
| Secondary | Area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. AUClast will be listed and summarized using descriptive statistics. |
| Secondary | Total systemic clearance for intravenous administration (CL) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. CL will be listed and summarized using descriptive statistics. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38753757 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05870579
GET https://conductscience.org/api/trials/v1/NCT05870579/registered