A Phase I/II, Open-label, Multi-center Trial 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.
Novartis Pharmaceuticals
Summary
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).
Description
Despite remarkable clinical results with the use of CDK4/6i, breast cancer patients will experience progression of disease requiring alternative treatment options. The optimal sequence of therapy after progression on CDK4/6i has not been established and it depends on multiple factors, including previous regimens, mutational profile, comorbidities, patient preference or disease burden (NCCN v4, 2023). Thus, new targeted treatment modalities are needed for treatment of patients with endocrine-resistant mBC. The purpose of this Phase I/II study conducted in participants with ER+/HER2-, gastrin r…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Participant is female or male adult ≥ 18 years old at the time of informed consent(s). 3. Participant has a histologically and/or cytologically documented diagnosis of ER+ breast cancer (ER expression \>10% of tumor cell nuclei stain (regardless of PgR expression) (based on the most recently analyzed tissue sample tested by a local laboratory). 4. Participant has HER2-negative (as per ASCO-CAP guidelines Wolff et al 2018) breast cancer defined as a negative in situ hybridization test (ISH)…
Interventions
- Drug[68Ga]Ga-NeoB
68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions.
- Drug[177Lu]Lu-NeoB
\[177Lu\]Lu-NeoB is a radioligand therapy drug.
- DrugCapecitabine
Capecitabine is a chemotherapy drug.
Locations (32)
- UCLA Medical CenterLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Mayo Clinic - RochesterRochester, Minnesota
- Uni Of TX MD Anderson Cancer CntrHouston, Texas
- University Of WisconsinMadison, Wisconsin
- Novartis Investigative SiteDarlinghurst, New South Wales