Phase II Clinical Study of Trastuzumab Emtansine (T-DM1) Combined With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitor Ribociclib in the Treatment of Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.
详细描述
This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Trastuzumab Emtansine (T-DM1) combined with CDK4/6 inhibitor Ribociclib in the treatment of unresectable locally advanced or metastatic HER2-positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 at the time of signing the informed consent.
- •Patient's ability to follow the study protocol as determined by the investigator.
- •A representative tumor tissue sample is required to confirm a HER2-positive diagnosis.
- •HER2 expression status and ER expression status of invasive cancer lesions were determined based on previous pathological sections or current pre-treatment biopsy materials, and the HER2 IHC assay was locally confirmed to be consistent with 3+, or IHC assay with 2+, and further FISH detection was positive before study enrollment.
- •At least one evaluable lesion was detected by CT or MRI (see protocol for additional details).
- •For metastatic or recurrent breast cancer, there is currently no opportunity for surgical radical resection.
- •Metastatic or recurrent breast cancer that has received at least first-line rescue therapy in the past must have been treated with trastuzumab and taxanes.
- •The Physical status (ECOG) score of the Eastern Tumor Collaboration group was 0 or
- •Sufficient haematology and organ function to meet the definition of laboratory test results, which must be provided within 14 days before the start of study therapy.
- •Fertile women should remain abstinent (no heterosexual intercourse) or use contraceptive methods.
排除标准
- •Past treatment with other antibody-drug conjugate (ADC) drugs or anti-tumor therapy with CDK4/6 inhibitors.
- •Past treatment with other anti-HER2 drugs other than trastuzumab, pertuzumab and tyrosine kinase inhibitors (TKI).
- •Advanced breast cancer with central nervous system metastasis.
- •Patients who have developed other malignancies in the 5 years prior to screening, except adequately treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.
- •Severe dysfunction of vital organs prior to enrollment (see protocol details).
- •Received an investigational drug within 28 days prior to initiation of study therapy.
- •Known hypersensitivity or hypersensitivity to CDK4/6 inhibitors.
- •The results of the serum pregnancy test were positive.
研究组 & 干预措施
T-DM1 combined with Ribociclib
Enrolled patients will receive (repeat every 21 days) :
● T-DM1 3.6 mg/kg d1;● Ribociclib 400 mg qd, d8-d21;
* ER-positive patients will receive endocrine therapy at the same time: aromatase inhibitors or fulvestrant , and ovarian suppression or ovariectomy in premenopausal women.
干预措施: Ribociclib Oral Tablet (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 54 months
ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Objective Response Rate of Subgroup Population (ORR)(up to 54 months)
- Adverse Event (AE)(up to 54 months)
- Progression-Free Survival (PFS)(up to 54 months)
- 2-year Overall Survival (OS)(up to 54 months)
研究者
Zheng Yabing
Deputy director
Zhejiang Cancer Hospital