58 Participants Needed

[177Lu]Lu-NeoB + Capecitabine for Metastatic Breast Cancer

(NeoB-Cap1 Trial)

Recruiting at 29 trial locations
NP
Overseen ByNovartis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants currently receiving brivudine or NEP inhibitors must discontinue these medications before starting the trial. It's best to discuss your specific medications with the trial team.

What makes the drug [177Lu]Lu-NeoB unique for treating metastatic breast cancer?

The drug [177Lu]Lu-NeoB is unique because it uses lutetium-177, a radioactive element, to target cancer cells directly, combining both imaging and treatment in one approach, which is different from traditional chemotherapy that affects the whole body.12345

What data supports the effectiveness of the drug [177Lu]Lu-NeoB for treating metastatic breast cancer?

Research on similar treatments using lutetium-177, like 177Lu-Dotatate for neuroendocrine tumors and 177Lu-PSMA for prostate cancer, shows promise in treating cancers by targeting specific molecules in cancer cells. These studies suggest that lutetium-177 can be effective in targeting and treating certain types of cancer, which may indicate potential for [177Lu]Lu-NeoB in metastatic breast cancer.12367

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of advanced breast cancer that's positive for certain receptors (GRPR+, ER+), negative for HER2, and has worsened after previous hormone therapy and CDK4/6 inhibitors. Participants must have measurable disease progression, may have received Enhertu® if HER2-low or PARP inhibitor therapy if they carry BRCA mutations.

Inclusion Criteria

I have signed the consent form to participate in the study.
I have at least one tumor that can be measured by medical imaging.
I have HER2-low breast cancer and may have been treated with Enhertu®.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks
1 visit (in-person) for PET/CT or PET/MRI imaging

Treatment

Participants receive [177Lu]Lu-NeoB in combination with capecitabine. Treatment cycles are every 3 or 6 weeks depending on the dose regimen.

Up to 18 months
Site visits approximately every 3 weeks for the first 9 months, then every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation, with a focus on long-term safety and survival.

5 years
Regular follow-up visits as per the Schedule of Assessments

What Are the Treatments Tested in This Trial?

Interventions

  • [177Lu]Lu-NeoB
Trial Overview [177Lu]Lu-NeoB combined with Capecitabine is being tested to find the best doses and schedules in patients with metastatic breast cancer. The study has two parts: Phase I to determine safe dosage levels, and Phase II to test the effectiveness of these dosages on tumor growth.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Dose D: [177Lu]Lu-NeoB 100mCi q6w + capecitabineExperimental Treatment3 Interventions
Group II: Dose C: [177Lu]Lu-NeoB 200mCi q6w + capecitabineExperimental Treatment3 Interventions
Group III: Dose B: [177Lu]Lu-NeoB 100mCi q3w + capecitabineExperimental Treatment3 Interventions
Group IV: Dose A: [177Lu]Lu-NeoB 150mCi q6w + capecitabineExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

The novel radiopharmaceutical agent 177Lu-DOTA-DG was successfully synthesized with a high radiochemical yield and demonstrated excellent stability in human serum for up to 120 hours, indicating its potential for safe use in cancer imaging and therapy.
In preclinical studies, 177Lu-DOTA-DG caused significantly more DNA damage in cancer cells compared to untreated cells, suggesting its efficacy as a targeted treatment for cancer tissues.
In vivo and in vitro evaluation of 177Lu-labeled DOTA-2-deoxy-D-glucose in mice. A novel radiopharmaceutical agent for cells imaging and therapy.Zhang, J., Wang, Z., Liu, H., et al.[2019]
In a study of 47 patients with progressive well-differentiated neuroendocrine tumors (NETs) treated with 177Lu-Dotatate, the median progression-free survival was 34.1 months, indicating the treatment's efficacy in managing these tumors over time.
Factors such as having 5 or more bone metastases, non-gastroenteropancreatic NETs, high levels of chromogranin A, and pre-existing ascites were identified as significant predictors of poorer overall survival, helping to identify patients who may benefit less from this therapy.
Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS).Swiha, MM., Sutherland, DEK., Sistani, G., et al.[2022]
Lutetium-177 coupled with a ligand for Prostate Specific Membrane Antigen ([177Lu]Lu-PSMA) is an innovative treatment for patients with advanced prostate cancer who have limited options after hormonal therapy and chemotherapy, requiring specific eligibility criteria including good health and adequate targeting of metastases.
The treatment involves four to six intravenous doses administered six weeks apart, with mild side effects such as dry mouth, fatigue, and bone marrow depression, and is currently available in select hospitals in the Netherlands, with broader access expected following EMA registration.
[Lutetium-177-PSMA in metastasized prostate carcinoma].van Golen, LW., Vogel, W., Lam, MGEH.[2023]

Citations

In vivo and in vitro evaluation of 177Lu-labeled DOTA-2-deoxy-D-glucose in mice. A novel radiopharmaceutical agent for cells imaging and therapy. [2019]
Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS). [2022]
[Lutetium-177-PSMA in metastasized prostate carcinoma]. [2023]
[Lutetium-177-PSMA in metastasized prostate carcinoma]. [2023]
UpFrontPSMA: a randomized phase 2 study of sequential 177 Lu-PSMA-617 and docetaxel vs docetaxel in metastatic hormone-naïve prostate cancer (clinical trial protocol). [2021]
A review of advances in the last decade on targeted cancer therapy using 177Lu: focusing on 177Lu produced by the direct neutron activation route. [2023]
Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals. [2023]
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