NCT06702618进行中（未招募）2 期
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined With Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6（CDK4/6)Inhibitor-Resistant, Hormone Receptor(HR)-Positive, Human Epidermal Growth Factor Receptor 2(HER2)-Negative Recurrent/Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 13
- 主要终点
- Objective Response Rate
研究概览
简要总结
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative Recurrent/Metastatic 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
- •Subjects voluntarily join the study, sign the informed consent form, and have good compliance
- •Aged 18 to 75 years, with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0~1; expected survival time of more than 3 months.
- •Postmenopausal or premenopausal/perimenopausal female patients
- •Progressed after prior treatment with CDK4/6 inhibitors
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- •Good major organ function
- •Women of childbearing potential must agree to use contraception during the study and for 6 months after its completion.
排除标准
- •Subjects with a previous pathological diagnosis of HER2-positive breast cancer.
- •Subjects with inflammatory breast cancer or occult breast cancer.
- •Subjects who have had or currently have other malignant tumors within 5 years prior to randomization.
- •Subjects with unresolved toxicity (greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1) from prior treatment, excluding alopecia.
- •Subjects who have undergone major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to the first dose.
- •Subjects with non-tumor-related unresolved wounds, ulcers, or fractures.
- •Subjects with multiple factors affecting oral medication intake and absorption.
- •Subjects with arterial or deep vein thrombotic events within 6 months prior to the first dose.
- •Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia, angina requiring anti-anginal medication, clinically significant valvular heart disease, or uncontrolled hypertension.
- •Subjects with a history of interstitial lung disease/pneumonitis (non-infectious) requiring steroid intervention or currently having interstitial lung disease/pneumonitis, or subjects with suspected interstitial lung disease/pneumonitis on screening imaging that cannot be excluded.
- •Subjects with active or uncontrolled serious infections (≥CTCAE Grade 2 infection) or unexplained fever >38.5°C within 28 days prior to the first dose.
- •Subjects with a history of abuse of psychotropic drugs that cannot be abstained from or those with psychiatric disorders.
- •Subjects with (pseudo) cirrhosis, active hepatitis.
- •Subjects with renal failure requiring hemodialysis or peritoneal dialysis.
- •Subjects with a history of immunodeficiency diseases, organ transplants, or hematopoietic stem cell transplants.
- •Subjects who have previously received fulvestrant or other oral Selective Estrogen Receptor Degrader (SERD) class drugs.
- •Subjects who have previously received anti-HER2 therapy.
- •Subjects who have previously received antibody-drug conjugate therapy.
- •Subjects who have participated in other anti-tumor clinical trials and taken investigational drugs within 4 weeks prior to the first dose.
- •Subjects judged by the investigator to have serious accompanying diseases that severely endanger the safety of the subject or affect the completion of the study, or subjects who are deemed unsuitable for enrollment for other reasons
研究组 & 干预措施
TQB3616 capsule+Fulvestrant Injection
Experimental
干预措施: TQB3616 capsule+Fulvestrant Injection (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Baseline up to 12 months
The proportion of patients achieving complete response and partial response among the total evaluable cases.
次要结局
- Progression Free Survival(Baseline up to 12 months)
- Duration of Response(Baseline up to 12 months)
- Adverse event (AE)(From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first))
- Disease Control Rate(Baseline up to 12 months)
- Clinical Benefit Rate(From the first dose to complete response, partial response, or stable disease for ≥24 weeks)
- Overall Survival(Baseline up to 24 months)
研究者
研究点 (13)
Loading locations...
相似试验
终止
2 期
A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung CancerAdvanced Lung CarcinomaNCT04924192Chia Tai Tianqing Pharmaceutical Group Co., Ltd.21
Unknown
2 期
TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Metastatic Castration-Resistant Prostate CancerProstatic Neoplasms, Castration-ResistantDrug Therapy, CombinationNCT05156450West China Hospital30
招募中
1 期
A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.Colorectal CancerNCT06010901Chia Tai Tianqing Pharmaceutical Group Co., Ltd.75
招募中
2 期
A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung CancerNon Small Cell Lung CancerNCT05913089Chia Tai Tianqing Pharmaceutical Group Co., Ltd.58
Unknown
1 期
Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System TumorsDigestive System TumorsNCT05139082Peking University60