ClinicaliQ Trial Snapshot
- 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. — Recruiting • Phase I • Oncology….
- What is being tested: [177Lu]Lu-NeoB, a novel radioligand therapeutic targeting GRPR-positive tumours, combined with capecitabine chemotherapy in a dose-escalation study to establish safe and effective dosing regimens.
- Patient eligibility overview: Adult patients with metastatic breast cancer that is GRPR+, ER+, HER2- who have progressed despite prior endocrine therapy combined with CDK4/6 inhibitors, representing a treatment-resistant patient population with limited options.
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What This Trial Is Studying
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).
Eligibility Snapshot
- : 1. Signed informed consent must be obtained prior to participation in the study.
- Participant is female or male adult ≥ 18 years old at the time of informed consent(s).
- 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).
- Participant has HER2-negative (as per ASCO-CAP guidelines Wolff et al 2018) breast cancer defined as a negative in situ hybridization test (ISH) or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative ISH (e.g., FISH, CISH, or SISH) (based on the most recently analyzed tissue sample tested by a local laboratory) is required. 5a. Participant received no more than three prior endocrine therapies (single agent or in combination with targeted therapy) regimen/s in the metastatic setting of which at least one included endocrine therapy in combination with a CDK4/6i. In addition: * in case of confirmed presence of deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation, the participant may also have received a PARP inhibitor-based therapy. * In case of HER2-low breast cancer…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.