EUCTR2018-000977-62-DE进行中（未招募）1 期
A randomised, open-label Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer - BARBICA
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
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Willing and able to provide written informed consent prior to study entry
- •2. Female = 18 years of age
- •3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
- •4. Histologically confirmed TNBC defined as:
- •ER negative with <1% of tumour cells positive on IHC or an IHC score (Allred) of =2
- •PR unknown or negative with <1% of tumour cells positive on IHC or Allred score of =2
- •HER2 negative with 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH
- •5. Node-positive (cT1-4 cN1-2 M0) and/or tumour size =2 cm (cT2-T4 cN0-2 M0) with no prior treatment; participants
- •entering the trial after undergoing a SLN biopsy will be eligible if they meet other entry criteria
- •6. Adequate haematologic and end-organ function within 28 days prior to the first study treatment defined by the
- •a. ANC = 1500 cells/µL (1.5 x 109/L) (without granulocyte colony-stimulating factor support within 2 weeks prior to
- •Cycle 1, Day 1)
- •b. Platelet count = 100,000/µL (100 x 109/L) (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- •c. Haemoglobin = 9.0 g/dL (90g/L) (patients may be transfused or receive erythropoietic treatment to meet this
- •criterion).
- •d. INR or aPTT = 1.5 x ULN (for patients not receiving therapeutic anticoagulation. Patients receiving therapeutic
- •anticoagulation must be on a stable anticoagulant regimen.
- •e. Serum creatinine = 1.5 x ULN or calculated creatinine clearance 50 ml/min
- •f. AST or ALT and ALP < 2.5 times the institutional upper limit of normal (ULN), bilirubin = 1.5 x ULN (patients with
- •known Gilbert disease who have serum bilirubin level = 3 × the institutional ULN may be enrolled).
- •7. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test within 14
- •days of Day 1 Cycle 1 of study treatment, preferably as close to the first dose as possible. Patients must agree to use
- •adequate contraception, defined as those methods with a failure rate of < 1 % per year, (see section 6.14) beginning
- •14 days before the first dose of study drug and for 12 months after the last dose of cyclophosphamide (or 5 months
- •after the last dose of atezolizumab, whichever is longer).
- •8. Ability to comply with the protocol
- •9. Representative formalin-fixed paraffin embedded (FFPE) breast tumour samples (at least 2 core needle biopsies)
- •with an associated pathology report, determined to be available and sufficient for central testing OR tumour accessible
- •for biopsy.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1. Evidence of metastatic breast cancer.
- •2. Received any systemic therapy or radiotherapy for current breast cancer disease before study entry
- •3. Prior exposure to any CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, anti-PD-1 or anti-PD-L1 antibody.
- •4. Concurrent bilateral invasive breast cancer
- •5. Inflammatory breast cancer
- •6. Active malignancy (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) within the past 36 months prior to study entry
- •7. Major surgery within the last 28 days or anticipation of the need for major surgery during study treatment; minor surgeries including insertion of an indwelling catheter, core needle biopsy, or sentinel lymph node biopsy is allowed.
- •8. Known intolerance to any of the study drugs or any of their excipients
- •9. Pre-existing peripheral neuropathy grade = 2
- •10. History of autoimmune disease
- •11. History of Type I or Type II diabetes mellitus requiring insulin. Patients who are on a stable dose of oral diabetes medication = 2 weeks prior to initiation of study treatment are eligible for enrolment.
- •12. History of idiopathic pulmonary fibrosis or organizing pneumonia
- •13. History of HIV infection
- •14. Known active hepatitis infection or hepatitis C.
- •15. Active tuberculosis
- •16. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •17. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
- •18. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
- •19. Current treatment with anti-viral therapy for HBV
- •20. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- •21. Patients receiving concomitant immunosuppressive agents or chronic systemic corticosteroids (=10 mg prednisolone or an equivalent dose of other anti-inflammatory corticosteroids) use for =28 days at the time of study entry except in cases outlined below: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed. Patients on stable low dose of corticosteroids
- •for at least two weeks before randomisation are allowed.
- •22. Significant cardiovascular disease, such as:
- •History of myocardial infarction, acute coronary syndromes or coronary angioplasty/stenting/bypass grafting within the past 6 months.
- •Congestive heart failure (CHF) New York Heart Association (NYHA) Class III or IV or history of CHF NYHA class III or IV, unless an echocardiogram or multigated acquisition scan performed within 3 months before day 1 reveals a left ventricular ejection fraction = 50%;
- •23. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigation
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