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Radioisotope Therapy

[177Lu]Lu-NeoB + Ribociclib + Fulvestrant for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive with ER >10% breast cancer

Adult female or male >= 18 years of age at the time of informed consent

Must not have

Current or recent use of systemic corticosteroids

Prior receipt of fulvestrant treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment till 8 weeks after end of treatment, assessed up to approximately 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the right dose of a treatment called \[177Lu\]Lu-NeoB when used with ribociclib and fulvestrant in patients with a specific type of

Who is the study for?

This trial is for adults with advanced breast cancer that's ER+, HER2-, and GRPR+. They should have had an early relapse after endocrine therapy or progressed on such therapy plus a CDK4/6 inhibitor. Participants need good heart rates, organ function, and performance status. Those who've relapsed within 12 months from endocrine therapy without subsequent progression on another line of treatment are excluded.

What is being tested?

[177Lu]Lu-NeoB combined with ribociclib and fulvestrant is being tested to find the best dose for treating certain advanced breast cancers. The study includes patients whose cancer has returned quickly after hormone treatments or worsened despite them.

What are the potential side effects?

Potential side effects may include reactions related to radiation exposure from [177Lu]Lu-NeoB, hormonal changes due to fulvestrant, bone marrow suppression, fatigue, nausea from chemotherapy agents like ribociclib, as well as possible impacts on heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is confirmed to be estrogen-receptor positive.

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I am 18 years old or older.

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My breast cancer is HER2 negative.

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My breast cancer cannot be cured and has spread or returned.

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I am fully active or have some restrictions but can still care for myself.

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My scans show a lesion that absorbs a specific tracer strongly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using or have recently used corticosteroids.

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I have previously received fulvestrant treatment.

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My cancer returned or worsened within 6 months after CDK4/6 inhibitor treatment.

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I am using substances that I cannot stop before starting the study treatment.

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I am currently taking NEP inhibitors.

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I had to lower my ribociclib dose because it was causing me harm.

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I am currently taking warfarin or similar blood thinners.

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I have been diagnosed with inflammatory breast cancer.

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My liver disease is moderately to severely advanced.

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I have a history of heart problems or current heart disease.

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I have received more than one type of treatment for my advanced cancer.

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I have recently undergone radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment till 8 weeks after end of treatment, assessed up to approximately 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment till 8 weeks after end of treatment, assessed up to approximately 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment till 8 weeks after end of treatment, assessed up to approximately 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and nature of DLTs during the DLT observation period

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Incidence of dose interruptions, discontinuation and dose reductions

Secondary study objectives

Absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions

Area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-NeoB

Clinical Benefit Rate (CBR)

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment5 Interventions

Participants will receive \[177Lu\]Lu- NeoB in combination with ribociclib and fulvestrant, in the dose escalation and the backfill parts of the study. Goserelin administration is only applicable for pre/peri-menopausal women and men.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~2420

Fulvestrant

2011

Completed Phase 3

~4030