EUCTR2019-003465-18-IT进行中（未招募）1 期
A randomised phase II trial evaluating the efficacy of a nivolumab monotherapy lead in window” or commencement of nivolumab concurrently with paclitaxel and carboplatin as neoadjuvant therapy in early stage triple negative breast cancers - Neo
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
- 108
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
- All
入选标准
- •1) Female or male, age >= 18 years
- •2) ECOG performance status 0-1
- •3) Previously untreated non-metastatic (M0) TNBC meeting Stage I or II criteria as assessed by the local investigator on the basis of mammogram (MMG) and/or ultrasound (US) of the breasts, and US or clinical examination of the axilla
- •a) Stage I c T1c cN0; Stage IIA cT1 cN1; cT2 cN0; Stage IIB cT2 cN1; cT3 cN0
- •4) Clinically node positive participants should undergo computed tomography (CT) scan or PET CT of chest/abdomen (and bone scan if clinically indicated) to exclude metastases.
- •5) Non-metastatic, potentially operable, unilateral triple negative breast cancer, histologically defined as:
- •a) ER negative: with < 1% of tumour cells positive for ER by IHC irrespective of staining intensity AND
- •b) PR negative: with < 10% tumour cells positive for PR by IHC irrespective of staining intensity; AND
- •c) HER2 negative: IHC 0 or 1+, or ISH (FISH or SISH) negative
- •6) Able to start study treatment within 14 days of randomisation
- •7) Surgery able to be undertaken within 4 weeks of final dose of neoadjuvant IV therapy. Pre-operative radiation is not permitted for any participant with operable cancer after final study treatment
- •8) Adequate organ function. All screening laboratory tests should be performed within 14 days of randomisation.
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1) Confirmed presence of AJCC 8th Edition anatomic Stage 3 or 4 disease
- •2) Tumour of any size considered inoperable at presentation
- •3) Multifocal or bilateral invasive breast cancer
- •4) Has received prior chemotherapy, targeted therapy, radiation therapy, immunotherapy that target immune checkpoints, co-stimulatory or co-inhibitory pathways for T-cell receptors within the past 12 months
- •5) Will be offered neoadjuvant breast radiation therapy
- •6) Undergone or planned for sentinel lymph node biopsy before study therapy
- •7) Currently participating and receiving study therapy or has participated in a study of an investigational therapeutic agent and received study therapy within 4 weeks before randomisation.
- •Note: participant will be excluded if he/she received an investigational therapeutic agent with anticancer or anti-proliferative intent within the last 12 months
- •8) Any concurrent anti-neoplastic therapy (i.e. chemotherapy, hormonal therapy, immunotherapy, extensive, non-palliative radiation therapy, or standard or investigational agents for treatment of breast cancer) not already specified in the protocol
- •9) Prior malignancy active within the previous 3 years before randomisation, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- •10) Other active malignancy requiring concurrent intervention
- •11) Has significant cardiovascular disease such as myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months, congestive cardiac failure NYHA classification IV or history of CHF NYHA III or IV
研究者
相似试验
进行中（未招募）
1 期
eoadjuvant Nivolumab and chemotherapy in stage I-II triple negative breast cancer.CTIS2024-512625-86-00ANZ Breast Cancer Trials Group Limited110
进行中（未招募）
1 期
Evaluation of 2nd or 3rd line treatment by Nivolumab monotherapy or Nivolumab plus Ipilimumab, for unresectable Mesothelioma patientsMalignant Pleural MesotheliomaEUCTR2015-004475-75-FRIFCT114
招募中
2 期
A randomized phase II study to evaluate efficacy of negative pressure wound therapy on prophylaxis of the incisional hernia after reversal of temporaly diverting stomatemporally diverting stoma to be planned to have closedJPRN-UMIN000030936Aichi Medical University70
进行中（未招募）
1 期
A randomized study to explore the efficacy and feasibility of rotations between sunitinib and everolimus versus sequential treatment of sunitinib and everolimus until progression in patients with renal cancer.EUCTR2012-001337-13-ESAPRO115
进行中（未招募）
1 期
A randomized study to explore the efficacy and feasibility of rotations between sunitinib and everolimus versus sequential treatment of sunitinib and everolimus until progression in patients with renal cancer.Metastatic clear cell renal cancerMedDRA version: 14.1Level: LLTClassification code 10038416Term: Renal clear cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001337-13-GRAPRO115