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这是一项关于乳腺癌的I 期 / II 期研究，登记的药物或干预包括[68Ga]Ga-NeoB；[177Lu]Lu-NeoB；Capecitabine，当前状态为研究进行中，已停止招募。登记地点显示中国天津有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
[68Ga]Ga-NeoB；[177Lu]Lu-NeoB；Capecitabine · I 期 / II 期
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- Novartis Investigative Site · 天津
公开的入选条件
- 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) 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 rec
- 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 (IHC 1+ or IHC 2+ with ISH negative as per ASCO-CAP guidelines Wolff et al 2023), the participant may also have received trastuzumab deruxtecan \[Enhertu®\]).
- 6\. Participant has metastatic breast cancer with radiologically confirmed progression of disease after the most recent therapy 7. Participant must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1. (a lesion at a previously irrad
联系前需要确认
请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号：NCT06247995；登记信息更新于 2026-09-11。