Investigator-initiated phase 1 study of nucleic acid medicine targeting PRDM14 in patients with breast cancer

Takahashi Shunji0 个研究点目标入组 12 人开始时间: 2020年1月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Patients with breast cancer who:
•*Pathologically diagnosed as breast cancer.
•*Recurrent breast cancer unresectable or with distant metastases that is indicated for systemic chemotherapy.
•*ECOG PS: 0-1.
•*Female between the ages 20 and 75 at the time of consent.
•*History of 2 or more types of chemotherapy including anthracyclines and taxanes, as adjuvant therapy, neoadjuvant therapy or chemotherapy for metastasis or recurrence.
•2. Meet specified values of laboratory tests for major organ function.
•3. Expect to survive for at least 3 months from the date of enrollment.
•4. Have an evaluable lesion by RECIST 1.1.
•5. Written consent to participate in the trial.

•1. HER2 positive
•2. Major surgery or the last intervention of other clinical trial completed within 4 weeks of enrollment, chemotherapy or endocrine therapy completed within 3 weeks of enrollment, or the last irradiation of radiation therapy completed within 2 weeks of enrollment,
•3. Double cancer.
•4. Complication or other general condition that is not appropriate to participate in the trial (e.g., infection, immunodeficiency, neurologic disease).
•5. Pulmonary fibrosis or respiratory failure requiring oxygen.
•6. HBV, HCV, or HIV infection.
•7. Serious cardiovascular disease.
•8. Metastases brain or spinal cord.
•9. Diabetes mellitus that is poorly controlled by drug administration.
•10. Allergy related to a substance contained in the investigational drug or a substance involved in the manufacture.
•11. Pregnancy, breast-feeding, or disagreement with appropriate contraception.
•12. Other case that is not appropriate to participate in the trial by the investigator.

发起方

Takahashi Shunji