JPRN-jRCT2080223647已完成2 期
Phase 2 study of KHK2375 in subjects with advanced or recurrent breast cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
研究概览
简要总结
o statistically significant difference in median PFS between the KHK2375 and placebo groups in the FAS population. Regarding safety, ADRs of Grade 3 or severer in worst severity were observed more frequently in the KHK2375 group (48 of 65 subjects [73.8%]) than in the placebo group (12 of 66 subjects [18.2%]). However, most of them were resolved with appropriate treatment, and no clinically significant problems were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1) Personally submitted voluntary written informed consent to participate in the study
- •2) Age >= 20 years at the time of consent
- •3) Histologically or cytologically confirmed breast cancer positive for estrogen receptor (ER) and/or progesterone receptor (PgR)
- •4) Human epidermal growth factor 2 (HER2)-negative
- •5) Stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is impossible
- •6) Pre/Peri- and postmenopausal women
- •Postmenopausal status is defined either by:
- •- Age >= 55 years and >= 1 year of amenorrhea
- •- Age < 55 years and >= 1 year of amenorrhea, with blood estradiol (E2) < 20 pg/mL
- •- Age < 55 years with hysterectomy, with ovaries and E2 < 20 pg/mL
- •- Surgical menopause with bilateral oophorectomy
- •Pre/perimenopausal women may be enrolled only if they agree to receive an luteinizing hormone-releasing hormone (LH-RH) agonist
- •7) ECOG performance status (PS) of 0 or 1 at enrollment
- •8) Measurable or nonmeasurable lesions per RECIST version 1.1 criteria
- •9) Subjects meeting either of the following criteria:
- •- History of treatment with a nonsteroidal aromatase inhibitor (AI) for advanced or recurrent breast cancer, and development of progressive disease (PD) after the most recent prior treatment
- •- No history of treatment with endocrine therapy for advanced or recurrent breast cancer that has recurred during or within 12 months after postoperative adjuvant therapy with an nonsteroidal AI
- •10) An adverse event for which a causal relationship to prior treatment cannot be denied (except alopecia) is Grade =< 1 in severity or has returned to the baseline level, i.e., the level before the start of the prior treatment.
- •11) The latest laboratory values obtained prior to enrollment must meet all of the following requirements:
- •- Hemoglobin concentration: >= 9.0 g/dL
- •- Platelet count: >= 100000/uL
- •- Neutrophil count: >= 1500/uL
- •- Serum creatinine: =< 2.0 mg/dL
- •- Total bilirubin in serum: < 1.5 X institutional upper limit of normal (=< 3 mg/dL for subjects with Gilbert's syndrome)
- •- AST and ALT: =< 3.0 X institutional upper limit of normal
排除标准
- •1) Endocrine therapy (except for LH-RH agonist), treatment with everolimus, treatment with a cyclin-dependent kinase inhibitor, or radiation therapy within 14 days before enrollment
- •Subjects with prior treatment with exemestane may be enrolled if they meet either of the following criteria:
- •- Start of treatment with exemestane for advanced or recurrent breast cancer within 28 days before enrollment
- •- Recurrence-free period >12 months after completion of treatment with exemestane as postoperative adjuvant therapy
- •For painful bone lesions or impending fractures, radiation therapy may be used concomitantly if there is a measurable or nonmeasurable lesion that is suitable for efficacy evaluation in a region other than the radiation field
- •2) Two or more prior chemotherapy regimens for advanced or recurrent breast cancer
- •3) Chemotherapy within 21 days before enrollment
- •4) Treatment with bisphosphonates or anti-RANKL antibody that is scheduled to be started within 7 days before the first dose of investigational product
- •5) History of or current central nervous system metastasis, or current leptomeningeal or periosteal disease
- •6) History of cancer other than breast cancer within 5 years, or concurrent cancer other than breast cancer (except for basal cell carcinoma of skin, squamous cell carcinoma of skin, and intraepithelial carcinoma of uterine cervix)
- •Subjects continuing to receive treatment for cancer other than breast cancer are ineligible for enrollment
- •7) Ongoing treatment with any other anticancer therapy or investigational product (Except for treatment with exemestane or radiotherapy as described in exclusion criterion 1)
- •8) Prior treatment with histone deacetylase inhibitor (e.g. valproate, vorinostat)
- •9) Known allergy to imidazoles, exemestane, or entinostat
- •10) Any medical or psychiatric condition that could affect compliance with the protocol, ability to give consent, or assessment of anticipated toxicities
- •11) Uncontrolled complications (e.g., active infections)
- •12) Positive for either hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody
- •13) Any other conditions unsuitable for the study in the opinion of the investigator or subinvestigator
研究者
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