EUCTR2017-002771-25-ES进行中（未招募）1 期
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo (GeparDouze) - GeparDouze
SABP Foundation Inc.0 个研究点目标入组 1,520 人开始时间: 2019年11月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,520
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
入选标准
- •1. The patient must have consented to participate. 2. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy. 3. Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. 4.Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization for central confirmation of TNBC status and for correlative science studies. 5. The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 (SP142) assay kit. Patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminate. Patients will be classified as positive, negative, or indeterminate for stratification purposes. 6. Patients must be > or = 18 years old. 7. Patient may be female or male. 8. The ECOG performance status must be 0-1. 9. The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2–N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3. 10. Ipsilateral axillary lymph nodes must be evaluated by imaging (ultrasound, and/or MRI) within 42 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. 11.Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor. 12. Blood counts performed within 28 days prior to randomization. 13. Evidence of adequate hepatic function performed within 28 days prior to randomization.
- •14.Patients with AST or ALT or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, abdominal ultrasound, PET-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion 13 are met. 15. Patients with alkaline phosphatase that is > ULN but < or = 2.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET-CT scan, or PET scan) supported by additional studies when indicated (CT, x-ray, MRI) performed within 28 days prior to randomization does not demonstrate metastatic disease. 16.Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in criteria 14 and 15) within 28 days prior to randomization. 17. Creatinine clearance > or = 50 mL/min performed within 28 days prior to randomization. 18.PT/INR < or = ULN within 28 days prior to randomization. For laboratories that do not report an ULN for the INR assay, use < or = 1.2 as the value for the ULN. Patients receiving therapeutic anti-coagulants are not eligible. 19.A serum TSH and AM (morning) cortisol performed within 28 days prior
排除标准
- •- Excisional biopsy or lumpectomy performed prior to study entry.
- •- FNA alone to diagnose the breast cancer.
- •- Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
- •- Definitive clinical or radiologic evidence of metastatic disease.
- •- Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
- •- Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- •- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
- •- Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
- •- Previous therapy with anthracyclines or taxanes for any malignancy.
- •- Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens.
- •- Uncontrolled hypertension defined as sustained systolic BP>150 mmHg or diastolic BP>90 mmHg. Patients requiring >=3 BP medications are not eligible.
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- •- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
- •- Known allergy or hypersensitivity to the components of the atezolizumab formulation.
- •- Known allergy or hypersensitivity to the components of the doxorubicin, cyclophosphamide, carboplatin, or paclitaxel formulations.
- •- Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations.
- •- Active or history of autoimmune disease or immune deficiency.
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •- Patients known to be HIV positive.
- •- Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.
- •Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
- •- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA.
- •- Patients with clinically active tuberculosis.
- •- Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- •- Prior allogeneic stem cell or solid or
研究者
相似试验
进行中（未招募）
1 期
eoadjuvant chemotherapy with Atezolizumab or Placebo followed by adjuvant Atezolizumab or PlaceboPatients with early breast cancerMedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-002771-25-DESABP Foundation Inc.1,550
进行中（未招募）
1 期
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo GeparDouzePatients with early breast cancerMedDRA version: 20.0Level: LLTClassification code: 10007050Term: Cancer Class: 10029104CTIS2023-508472-11-00SABP Foundation Inc.1,550
尚未招募
3 期
CV638 ability to protect against homologous Vibrio cholerae 3008 virulent straicholera infectionVibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsWaterborne DiseasesEnvironmental IllnessCholeraRPCEC00000228Finlay Institute of Vaccines (IFV)120
进行中（未招募）
不适用
sitagliptin +simvastatin coadministration safety studyType 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-001868-29-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.750
进行中（未招募）
不适用
sitagliptin +simvastatin coadministration safety studyEUCTR2012-001868-29-LTMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.750