Actively Recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
Led by Novartis Pharmaceuticals · Updated on 2025-11-06
58
Participants Needed
32
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).
CONDITIONS
Official Title
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained before participation
- Adults aged 18 years or older, female or male
- Diagnosed with estrogen receptor-positive breast cancer with over 10% tumor cell expression
- HER2-negative breast cancer confirmed by specific testing
- Received no more than three prior endocrine therapy regimens for metastatic disease, including at least one with CDK4/6 inhibitor
- Metastatic breast cancer with progression confirmed by imaging after most recent therapy
- Measurable disease with at least one lesion evaluable by RECIST 1.1 criteria
- Tumors showing [68Ga]Ga-NeoB uptake greater than liver uptake on PET imaging
- Stable and clinically controlled central nervous system involvement if present
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver, kidney function, and other laboratory values per protocol
- Able to swallow capecitabine tablets
- Able to communicate and comply with study procedures
- Female participants in Phase I and Japanese cohort must be postmenopausal; males must not require gonadotropin releasing hormone agonists
- Female participants in Phase II may be pre/peri- or postmenopausal; males included regardless of hormone therapy needs
You will not qualify if you...
- Symptomatic visceral disease or disease burden posing life-threatening risks
- More than one prior chemotherapy or antibody drug-conjugate treatment for metastatic disease
- Prior treatment with capecitabine
- Known allergic reactions or contraindications to study drugs or similar substances
- Inflammatory breast cancer at screening
- Major surgery within 14 days before starting treatment or not recovered from side effects
- Prior therapeutic radiopharmaceutical treatment
- Prior external beam radiation therapy to over 25% of bone marrow
- Other cancers within 3 years except certain treated skin or cervical cancers
- Gastrointestinal conditions affecting drug absorption
- Severe or uncontrolled medical conditions that increase safety risk
- History of acute pancreatitis within one year
- Significant heart disease or ECG abnormalities posing safety risks
- Uncontrolled high blood pressure
- Current use of brivudine that cannot be stopped before capecitabine
- Current use of NEP inhibitors preventing dosimetry imaging
- Known deficiency of dihydropyrimidine dehydrogenase
- Participation in another investigational study within 30 days or 5 half-lives of treatment
- Male participants unwilling to use contraception or abstain sexually during and after treatment
- Inability to provide informed consent if required
- In Phase II, pregnant or breastfeeding women and women of childbearing potential not using effective contraception
- Use of hormonal contraceptives not allowed
- Use of prohibited therapies listed in protocol section 6.8.2
AI-Screening
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Trial Site Locations
Total: 32 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
3
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States, 77030
Actively Recruiting
5
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
6
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
7
Novartis Investigative Site
Malvern, Victoria, Australia, 3144
Actively Recruiting
8
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
9
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
10
Novartis Investigative Site
Guangzhou, China, 510060
Actively Recruiting
11
Novartis Investigative Site
Tianjin, China, 300308
Actively Recruiting
12
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
13
Novartis Investigative Site
Grenoble, France, 38043
Actively Recruiting
14
Novartis Investigative Site
Saint-Herblain, France, 44805
Actively Recruiting
15
Novartis Investigative Site
Strasbourg, France, 67200
Actively Recruiting
16
Novartis Investigative Site
Villejuif, France, 94800
Actively Recruiting
17
Novartis Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
18
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
19
Novartis Investigative Site
Tübingen, Germany, 72076
Actively Recruiting
20
Novartis Investigative Site
Meldola, FC, Italy, 47014
Actively Recruiting
21
Novartis Investigative Site
Reggio Emilia, RE, Italy, 42123
Actively Recruiting
22
Novartis Investigative Site
Delft, South Holland, Netherlands, 2625 AD
Actively Recruiting
23
Novartis Investigative Site
Porto, Portugal, 4200-072
Actively Recruiting
24
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
25
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
26
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
27
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
28
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
29
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
30
Novartis Investigative Site
Seville, Spain, 41013
Actively Recruiting
31
Novartis Investigative Site
London, United Kingdom, W12 0HS
Actively Recruiting
32
Novartis Investigative Site
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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