JPRN-jRCTs051220133招募中2 期
Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients- Multi-institutional phase 2 trial- - JBCRG-M08 AMBER trial
Yoshinami Tetsuhiro0 个研究点目标入组 150 人开始时间: 2022年12月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •primary enrollment
- •(1) Histologically diagnosed with invasive breast cancer.
- •(2) Confirmed ER-positive or PgR-positive (>= 1% positive cells by IHC or an Allred score of >= 3).
- •(3) Confirmed HER2-negative (IHC 0 or 1, or FISH/DISH-negative).
- •(4) Diagnosed with advanced or metastatic breast cancer.
- •*Advanced breast cancer refers to the condition with curatively unresectable lesions, and metastatic breast cancer refers to the condition with distant metastases.
- •*The patient does not have measurable or non-measurable lesions per RECIST ver 1.1 (lesions do not need to be present) at enrollment if the patient has been radiographically diagnosed with advanced metastatic breast cancer prior to initiation of first-line aromatase inhibitor + abemaciclib combination therapy.
- •(5) Age >= 18 years at the time of informed consent.
- •(6) Postmenopausal women.
- •(7) Performance status (PS) of 0 or 1 according to the ECOG criteria.
- •(8) Aromatase inhibitor + abemaciclib combination therapy has been administered as the first-line treatment for advanced metastatic breast cancer, and both drugs have been continued for >= 6 to < 12 months at the time of the primary enrollment. The patient should meet all of the following criteria (a) to (c).
- •(a) Each dose of abemaciclib is 150, 100, or 50 mg and has been taken twice daily.
- •(b) The aromatase inhibitor is letrozole or anastrozole.
- •(c) Aromatase inhibitor + abemaciclib combination therapy has been started under any of the following conditions:
- •- In the case of Stage IV (de novo) disease at diagnosis, drug therapy has not been administered.
- •- In the case of postoperative recurrence, drug therapy has not been administered after recurrence. In addition, if postoperative therapy has been performed, it has to be recurrence at least 1 year after the completion of endocrine therapy as postoperative therapy, and the preoperative and postoperative therapy must not include CDK4/6 inhibitors.
- •(9) No evidence of progressive disease based on radiographic evaluation within 6 weeks before the day of enrollment.
- •(10) No active interstitial pneumonia confirmed by CT within 6 weeks before the day of enrollment.
- •(11) Non-hematologic toxicities (excluding alopecia) with aromatase inhibitor + abemaciclib combination therapy controlled at Grade <= 2 according to CTCAE v 5.0.
- •(12) Meeting the following criteria in blood test within 28 days before the day of enrollment.
- •[1] Absolute neutrophil count (ANC) >=1,500/mm3 (>=1.5 x 109/L)
- •[2] Hemoglobin >= 8.0 g/dL*
- •(*Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
- •[3] Platelet count >= 10 x 104/mm3 (100x109/L)
- •[4] Total bilirubin <= 1.5 mg/dL*1
- •*1 Patients with Gilbert's syndrome with a total bilirubin <=2.0 times ULN and direct bilirubin within normal limits are permitted.
- •[5] AST (GOT) <= 120 IU/L
- •[6] ALT (GPT) <= 120 IU/L
- •[7] Serum creatinine <= 2.0 mg/dL*
- •*Even if the above value is exceeded, the patient may be enrolled if the renal function is confirmed to be normal based on the measurement of serum cystatin C within 28 days before the day of primary enrollment.
- •(13) Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade <=1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at
排除标准
- •primary enrollment
- •(1) The patient has concurrent or history of interstitial lung disease (ILD)/pneumonitits, including lung fibrosis.
- •(2) Patients with central nervous system metastases or carcinomatous meningitis, either active or inactive.
- •(3) Patients with active double cancer (synchronous or metachronous with disease-free period within 2 years before the day of primary enrollment) other than breast cancer. However, even if the disease-free period is < 2 years before the day of primary enrollment, a history of the following will not be included in the active double cancer: laryngeal cancer in clinical stage 0 or I for which complete response was achieved by radiotherapy; and cancers for which 5-year relative survival is >= 95% such as those in the following pathological stages that were totally resected:
- •- Gastric cancer adenocarcinoma (common type), stage 0 to I; colon cancer (adenocarcinoma), stage 0 to I; rectal cancer (adenocarcinoma), stage 0 to I; esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma), stage 0; and endometrial cancer
- •- (Endometrioid adenocarcinoma and mucinous adenocarcinoma), stage I; cervical cancer (squamous cell carcinoma), stage 0; thyroid cancer (papillary carcinoma and follicular carcinoma), stages I, II, and III; renal cancer (clear cell carcinoma and chromophobe cell carcinoma), stage I; and other lesions equivalent to intramucosal carcinoma
- •- In principle, staging will follow the UICC TNM 7th edition or equivalent cancer handling rules.
- •(4) Patients with a history of breast cancer other than hormone receptor-positive, HER2-negative breast cancer that is synchronous or for which the disease-free period is < 5 years before the day of primary enrollment (excluding curatively resected non-invasive cancer).
- •(5) The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- •(6) Patients with known infection with HBV or HCV or HIV. HBV infection is defined as HBs antigen-positive, or HBs antigen-negative and HBc antibody- or HBs antibody-positive with the quantified HBV-DNA level being equal to or higher than the detection sensitivity.
- •However, confirmation at screening is not essential for these assessments. It is desirable that HBV and HCV are confirmed to be negative regardless of the timing of test.
- •(7) Patients with a complication or history of heart failure of NYHA class II to IV, ischemic heart disease, or arrhythmia requiring treatment (excluding paroxysmal supraventricular tachycardia and atrial fibrillation with a resting rate of <= 100 bpm).
- •(8) The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- •(9) Patients with poorly controlled diabetes mellitus (casual blood glucose level of >= 300 mg/dL or HbA1c of >= 8.0%).
- •(10) Patients with poorly controlled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg).
- •(11) Patients with symptoms of dyspnea at rest.
- •(12) Patients with pleural effusion, ascites, or cardiac effusio
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