[177Lu]Lu-NeoB + Capecitabine for Metastatic Breast Cancer
(NeoB-Cap1 Trial)
Recruiting in Palo Alto (17 mi)
+25 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Novartis Pharmaceuticals
Must not be taking: Brivudine, NEP inhibitors
Disqualifiers: Visceral disease, Inflammatory breast cancer, others
No Placebo Group
Trial Summary
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 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.
12345What 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.
13467Eligibility Criteria
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®.
+7 more
Trial Timeline
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
Participant Groups
[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.
4Treatment groups
Experimental Treatment
Group I: Dose D: [177Lu]Lu-NeoB 100mCi q6w + capecitabineExperimental Treatment3 Interventions
\[177Lu\]Lu-NeoB 100mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
Group II: Dose C: [177Lu]Lu-NeoB 200mCi q6w + capecitabineExperimental Treatment3 Interventions
\[177Lu\]Lu-NeoB 200mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
Group III: Dose B: [177Lu]Lu-NeoB 100mCi q3w + capecitabineExperimental Treatment3 Interventions
\[177Lu\]Lu-NeoB 100mCi q3w+ Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
Group IV: Dose A: [177Lu]Lu-NeoB 150mCi q6w + capecitabineExperimental Treatment3 Interventions
\[177Lu\]Lu-NeoB 150mCi q6w + Capecitabine 1000mg/ m2 BID Day1-14 in a 21-day schedule
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novartis Investigative SiteMontreal, Canada
Uni Of TX MD Anderson Cancer CntrHouston, TX
University Of WisconsinMadison, WI
Novartis Investigative SiteToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor
References
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]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Incorporation of lutetium-177 (177Lu) into suitable molecules that are implicated in cancer pathology represents a promising approach for the diagnosis and treatment of cancer. The goal of the present study was to develop a novel 177Lu labeled radiopharmaceutical agent for both radioimaging and targeted radionuclide therapy.
Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS). [2022]Label="PURPOSE" NlmCategory="OBJECTIVE"> 177Lu-Dotatate is an emerging treatment modality for patients with unresectable or metastatic well-differentiated NETs. This study examines survival predictors in patients who received 177Lu-Dotatate.
[Lutetium-177-PSMA in metastasized prostate carcinoma]. [2023]Lutetium-177 coupled with a ligand for Prostate Specific Membrane Antigen ([177Lu]Lu-PSMA) is a new treatment in The Netherlands. Patients with metastasized castration resistant prostate carcinoma and progressive disease after hormonal therapy and chemotherapy, and no other regular therapeutic options, can be referred. A good clinical performance state, adequate bone marrow function and a PSMA PET/CT showing adequate targeting in all metastases are essential. The therapy consists of four to six intravenous administrations of 7.4 GBq [177Lu]Lu-PSMA, six weeks apart. Side effects are mild and consist of xerostomia, fatigue and bone marrow depression. This therapy is currently administered only in a few hospitals in The Netherlands, mainly in research setting. An EMA registered product is expected at the end of 2022, which can contribute to better availability for reimbursed treatment.
[Lutetium-177-PSMA in metastasized prostate carcinoma]. [2023]Lutetium-177 coupled with a ligand for Prostate Specific Membrane Antigen ([177Lu]Lu-PSMA) is a new treatment in The Netherlands. Patients with metastasized castration resistant prostate carcinoma and progressive disease after hormonal therapy and chemotherapy, and no other regular therapeutic options, can be referred. A good clinical performance state, adequate bone marrow function and a PSMA PET/CT showing adequate targeting in all metastases are essential. The therapy consists of four to six intravenous administrations of 7.4 GBq [177Lu]Lu-PSMA, six weeks apart. Side effects are mild and consist of xerostomia, fatigue and bone marrow depression. This therapy is currently administered only in a few hospitals in The Netherlands, mainly in research setting. An EMA registered product is expected at the end of 2022, which can contribute to better availability for reimbursed treatment.
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]Label="OBJECTIVE">To assess the activity and safety of sequential lutetium-177 (177 Lu)-PSMA-617 and docetaxel vs docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone-naïve prostate cancer (mHNPC).
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]Lutetium-177 [T½ = 6.76 d; Eβ (max) = 0.497 MeV; maximum tissue range ~2.5 mm; 208 keV γ-ray] is one of the most important theranostic radioisotope used for the management of various oncological and non-oncological disorders. The present review chronicles the advancement in the last decade in 177Lu-radiopharmacy with a focus on 177Lu produced via direct 176Lu (n, γ) 177Lu nuclear reaction in medium flux research reactors. The specific nuances of 177Lu production by various routes are described and their pros and cons are discussed. Lutetium, is the last element in the lanthanide series. Its chemistry plays a vital role in the preparation of a wide variety of radiopharmaceuticals which demonstrate appreciable in vivo stability. Traditional bifunctional chelators (BFCs) that are used for 177Lu-labeling are discussed and the upcoming ones are highlighted. Research efforts that resulted in the growth of various 177Lu-based radiopharmaceuticals in preclinical and clinical settings are provided. This review also summarizes the results of clinical studies with potent 177Lu-based radiopharmaceuticals that have been prepared using medium specific activity 177Lu produced by direct neutron activation route in research reactors. Overall, the review amply demonstrates the practicality of the medium specific activity 177Lu towards formulation of various clinically useful radiopharmaceuticals, especially for the benefit of millions of cancer patients in developing countries with limited reactor facilities.
Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals. [2023]Peptide receptor radionuclide therapy (PRRT) using Lutetium-177 (177Lu) based radiopharmaceuticals has emerged as a therapeutic area in the field of nuclear medicine and oncology, allowing for personalized medicine. Since the first market authorization in 2018 of [¹⁷⁷Lu]Lu-DOTATATE (Lutathera®) targeting somatostatin receptor type 2 in the treatment of gastroenteropancreatic neuroendocrine tumors, intensive research has led to transfer innovative 177Lu containing pharmaceuticals to the clinic. Recently, a second market authorization in the field was obtained for [¹⁷⁷Lu]Lu-PSMA-617 (Pluvicto®) in the treatment of prostate cancer. The efficacy of 177Lu radiopharmaceuticals are now quite well-reported and data on the safety and management of patients are needed. This review will focus on several clinically tested and reported tailored approaches to enhance the risk-benefit trade-off of radioligand therapy. The aim is to help clinicians and nuclear medicine staff set up safe and optimized procedures using the approved 177Lu based radiopharmaceuticals.