EUCTR2016-004424-38-DE进行中（未招募）1 期
A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer. - ECLIPSE: Preoperative immunotherapy combinations in breast cancer
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
- 97
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 operable primary breast cancer
- •5. Palpable breast tumour of any size, or tumour with an ultrasound / MRI size of = 1 cm or mammogram
- •6. ER+ tumours defined as tumours with =1% of tumour cells positive for ER on IHC staining or an IHC score (Allred) of = 3
- •7. HER2-negative tumours defined as 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH.
- •8. Patients with either: (a) Luminal B breast cancer defined as: high Ki67 defined as =20% and /or histological grade 3 and / or Luminal B according to PAM50 assay OR (b) Non-Luminal B breast cancer
- •9. Adequate haematologic and end-organ function within 28 days prior to the first study treatment.
- •10. 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, beginning 14 days before the first dose of study drug and for 6 months after the last dose of study drug.
- •11. Ability to comply with the protocol
- •12. Representative formalin-fixed paraffin embedded (FFPE) breast tumour samples with an associated pathology report that are 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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Inflammatory breast cancer
- •2. Concurrent use of HRT.
- •3. Previous systemic or local treatment for the new primary breast cancer currently under investigation; prior treatment for previous breast cancer or other neoplasms is allowed as long as it was completed =1 year prior to Day 1 Cycle 1.
- •4. Previous systemic treatment for other neoplasms within 1 year prior to randomisation.
- •5.Patients with prior allogeneic stem cell or solid organ transplantation.
- •6. Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti- PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- •7.Patients must not have had oral or IV steroids for 14 days prior to study entry; the use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids and mineralocorticoids is allowed.
- •8. Received therapeutic oral or intravenous antibiotics <14 days prior to randomisation.
- •9. Administration of a live, attenuated vaccine <28 days prior to randomisation, treatment, or within 5 months following the last dose of atezolizumab.
- •10. Treatment with systemic immunostimulatory agents <28days or five half-lives of the drug, whichever is shorter, prior to enrolment.
- •11. History of autoimmune disease. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement therapy may be eligible for the study following discussion with the medical monitor.
- •12. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan.
- •13. History of HIV infection
- •14. Known active hepatitis infection or hepatitis C.
- •15. Active tuberculosis
- •16. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •17. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
- •18. 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 investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
- •19. Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
- •20. Concurrent treatment with other experimental drugs or participation in another clinical trial with therapeutic intent < 28 days prior to randomisation.
- •21. Pregnant and lactating female patients.
- •22. Major surgical procedure < 4 weeks prior to randomisation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
- •23. Malignancies other than breast cancer < 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- •24. Severe infections < 28 days prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- •25. Significant cardiovascular disease.
- •26. Evidence of bleeding diathesis or coagulopathy.
- •27. Inability to swallow medication or malabsorption condition that would alter the absorption of orally administered medications.
- •28. Clinically significant abnormalities of glucose met
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