EUCTR2021-005081-17-DE进行中（未招募）1 期
An Open-Label, Randomized, Non-Comparative Phase 2 Study of ARV-471 or Anastrozole in Post-Menopausal Women With ER+/HER2– Breast Cancer in the Neoadjuvant Setting
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- Female
入选标准
- •Participants, for whom neoadjuvant endocrine monotherapy is deemed appropriate, are eligible to be included in the study only if all of the following criteria apply:
- •1. Post-menopausal females = 18 years
- •2. Histologically or cytologically confirmed ER+ and HER2– breast cancer (per local assessment)
- •3. Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer
- •4. The primary tumor must be at least 1.5 cm by imaging
- •5. Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection
- •6. Capable of giving signed informed consent
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •8. Adequate bone marrow function
- •9. Activated partial thromboplastin time (aPTT) = 1.25 × upper limit of normal (ULN) and international normalized ratio (INR) = 1.25
- •10. Adequate renal function defined as serum creatinine of = 1.5 × ULN or an estimated creatinine clearance of = 50 mL/min by Cockcroft Gault
- •11. Adequate liver function
- •12. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Any other active malignancy within three years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
- •2. Any of the following in the previous six months:
- •- Myocardial infarction
- •- Severe / unstable angina
- •- Coronary / peripheral artery bypass graft
- •- Symptomatic congestive heart failure (New York Heart Association class III or IV)
- •- Cerebrovascular accident
- •- Transient ischemic attack
- •- Symptomatic pulmonary embolism
- •3. Any of the following in the previous six months:
- •- Congenital long QT syndrome
- •- Torsade de Pointes
- •- Sustained ventricular tachyarrhythmia and ventricular fibrillation
- •- Left anterior hemiblock (bifascicular block)
- •- Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) = Grade 2
- •- Atrial fibrillation of any grade (= Grade 2 in the case of asymptomatic lone atrial fibrillation).
- •4. Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery
- •5. Cirrhosis meeting criteria for Child Pugh B and C
- •6. Major surgery (as defined by the Investigator) within four weeks of first dose of study drug
- •7. History of allergy or reaction to any of the drug components for ARV-471 or anastrozole, including patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •8. Inability to take oral medication without crushing, dissolving, or chewing tablets
- •9. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study
- •10. Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents
- •11. Any live vaccines within 14 days of planned start of first dose of study drug
- •12. Taking the following agents within 14 days of C1D1 unless otherwise specified:
- •- Sensitive P-glycoprotein (P-gp) substrates or P-gp substrates with narrow therapeutic indices
- •- Strong CYP3A4 inhibitors or inducers
- •- Any medications with known QT risk, and/or are associated with a risk of Torsades de Pointes, within 7 days of C1D1
- •13. Corrected QT interval by Fredericia’s method (QTcF) > 470 msec
- •14. Participants with active, uncontrolled bacterial, fungal or viral infection, including (but not limited to) hepatitis B virus (HBV) and hepatitis C virus (HCV) and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- •15. Participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Sponsor approval is required.)
- •16. Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •17. Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
研究者
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