Actively Recruiting
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
Led by Novartis Pharmaceuticals · Updated on 2026-04-30
48
Participants Needed
25
Research Sites
428 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female or male 18 years of age or older at the time of informed consent
- Confirmed diagnosis of estrogen receptor positive breast cancer with ER >10%
- HER2 negative breast cancer verified by local laboratory testing
- Advanced breast cancer that is locoregionally recurrent or metastatic
- Relapsed within 12 months from (neo)adjuvant endocrine therapy without advanced disease treatment, or relapsed >12 months and progressed after one line of endocrine therapy (except fulvestrant), or advanced breast cancer at diagnosis progressed after one line of endocrine therapy (except fulvestrant)
- At least one measurable target lesion showing uptake on PET imaging using [68Ga]Ga-NeoB
- Adequate bone marrow and organ function
- QTcF interval less than 450 msec and resting heart rate between 50-90 bpm
- ECOG performance status of 0 or 1
You will not qualify if you...
- More than one prior treatment line for advanced/metastatic breast cancer
- Prior treatment with fulvestrant
- Previous ribociclib dose reduction due to safety concerns
- Relapse or progression within 6 months after CDK4/6 inhibitor therapy
- Symptomatic visceral disease or disease burden unsuitable for ribociclib plus endocrine therapy
- Central nervous system involvement unless stable and off steroids or enzyme-inducing anti-epileptics for at least 4 weeks
- Current use of warfarin or Coumadin anticoagulants
- Diagnosis of inflammatory breast cancer
- Child Pugh score B or C
- History or current significant cardiac disease or ECG abnormalities
- Known allergy to study drugs or their components
- Recent radiopharmaceutical treatment without sufficient clearance time
- Recent radiotherapy with unresolved side effects affecting safety
- Recent systemic corticosteroid use without recovery
- History of acute pancreatitis within 1 year
- Current use of medications or supplements affecting cytochrome P450 3A4 metabolism or prolonging QT interval that cannot be discontinued
- Current use of NEP inhibitors preventing dosimetry imaging
- Other protocol-specified criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 25 locations
1
UCLA Jonsson Comp Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
3
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Actively Recruiting
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
Utah Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
7
Novartis Investigative Site
Guangzhou, China, 510060
Actively Recruiting
8
Novartis Investigative Site
Shanghai, China, 200032
Actively Recruiting
9
Novartis Investigative Site
Tianjin, China, 300300
Actively Recruiting
10
Novartis Investigative Site
Saint-Cloud, Hauts De Seine, France, 92210
Actively Recruiting
11
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
12
Novartis Investigative Site
Clermont-Ferrand, France, 63011
Actively Recruiting
13
Novartis Investigative Site
Saint-Herblain, France, 44805
Actively Recruiting
14
Novartis Investigative Site
Strasbourg, France, F 67085
Actively Recruiting
15
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
16
Novartis Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
17
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
18
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
19
Novartis Investigative Site
Gliwice, Poland, 44 101
Actively Recruiting
20
Novartis Investigative Site
Porto, Portugal, 4200-072
Actively Recruiting
21
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
22
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
23
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
24
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
25
Novartis Investigative Site
Madrid, Spain, 28040
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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