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Study of [177Lu]Lu-NeoB with Ribociclib and Fulvestrant for Advanced Breast Cancer

This study is testing a new combination of treatments for advanced breast cancer that is Estrogen Receptor positive (ER+), HER2 negative, and Gastrin Releasing Peptide Receptor positive (GRPR+). You might be eligible if your cancer has returned early after previous hormone therapy, or if it has progressed while on hormone therapy with a CDK4/6 inhibitor. The study will use [177Lu]Lu-NeoB, a radioactive drug, along with ribociclib and fulvestrant, which are existing breast cancer medications. Before treatment, you will receive an imaging agent called [68Ga]Ga-NeoB for PET scans to find GRPR+ areas. The main goal is to find the safest and most effective dose of [177Lu]Lu-NeoB in this combination, and to understand any side effects. Researchers will also look at how well the treatment works.

Study design
This interventional study plans to enroll 28 participants. It has a dose escalation part to find the right dose of [177Lu]Lu-NeoB, and a backfill part to gather more safety and effectiveness information.
What's involved
You will receive [177Lu]Lu-NeoB once per cycle, ribociclib daily for 21 days every 28 days, and fulvestrant on specific days. Imaging with [68Ga]Ga-NeoB will occur at screening, potentially during treatment, and after your last dose of [177Lu]Lu-NeoB.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from enrollment until 8 weeks after treatment ends, and assessed for up to approximately 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05870579

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~28 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:[68Ga]Ga-NeoB[177Lu]Lu-NeoBRibociclibFulvestrantGoserelin

At a glance

Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and nature of DLTs during the DLT observation period
Measured over 28 days after the first administration of [177Lu]Lu-NeoB
+2 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaGRPR Gene

Where it's being run

13 sites across 10 states
Spain3
France2
California1
Texas1
China1
Hauts De Seine1
North Rhine-Westphalia1
Poland1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Adult female or male \>= 18 years of age at the time of informed consent
Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive with ER \>10% (regardless of progesterone receptor (PgR) expression) breast cancer by local laboratory testing (based on the most recently analyzed tissue sample)
HER2 negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (e.g. fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), or silver in situ hybridization (SISH)) test is required by local laboratory testing (based on the most recently analyzed tissue sample)
Participant has advanced (loco regionally recurrent not amenable to curative therapy (e.g. surgery and/or radiotherapy) or metastatic) breast cancer
Adequate bone marrow and organ function as defined by the laboratory values.
Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed locally:
QT interval corrected by Fridericia's formula (QTcF) interval at screening \< 450 msec
Mean resting heart rate 50-90 bpm (determined from the ECG)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion

More than one line of prior treatment in the advanced/metastatic setting. Participant shouldn't have received prior fulvestrant treatment.
Documented evidence of prior ribociclib dose reduction due to safety reasons either in adjuvant setting or for advanced disease.
Relapse or disease progression within 6 months of receiving a CDK4/6 inhibitor therapy either in adjuvant setting or for advanced disease. Symptomatic visceral disease or any disease burden that makes the participant ineligible for ribociclib plus endocrine treatment per the Investigator's best judgment.
Presence of central nervous system (CNS) involvement unless meeting BOTH of the following criteria: 1) At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment. 2) Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
Currently receiving warfarin or other Coumadin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin, or fondaparinux is allowed.
Diagnosis of inflammatory breast cancer at screening
Child Pugh score B or C
History or current diagnosis of impaired cardiac function, clinically significant cardiac disease or ECG abnormalities indicating significant risk of safety for participants.
Known or expected hypersensitivity to any of the study drugs or any of their excipients.
Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of \[68Ga\]Ga-NeoB or \[177Lu\]Lu-NeoB
Participant has received extended-field RT=\< 4 weeks or limited field RT=\< 2 weeks prior to start of treatment and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the participant at Investigator's discretion) and/or prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow.
Participant is currently receiving or has received systemic corticosteroids =\< 2 weeks prior to starting study treatment, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
Participant has a history of or ongoing acute pancreatitis within 1 year of screening.
Participant is currently receiving any of the following substances and cannot be discontinued 7 days prior to starting study treatment:
Concomitant medications, herbal supplements, and/or fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of cytochrome P450 (CYP) 3A4
Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointes (TdP) that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study treatment)
Participant is currently receiving NEP inhibitors (e.g.Entresto®, racecadotril) and images for dosimetry assessments cannot be acquired for this participant.

What this trial measures

  • Incidence and nature of DLTs during the DLT observation period28 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.

  • 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.

  • Incidence of dose interruptions, discontinuation and dose reductionsFrom 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.