[177Lu]Lu-NeoB + Capecitabine for Metastatic Breast Cancer
(NeoB-Cap1 Trial)
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?
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive [177Lu]Lu-NeoB in combination with capecitabine. Treatment cycles are every 3 or 6 weeks depending on the dose regimen.
Follow-up
Participants are monitored for safety and effectiveness after treatment discontinuation, with a focus on long-term safety and survival.
What Are the Treatments Tested in This Trial?
Interventions
- [177Lu]Lu-NeoB
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD