2024-512625-86-00招募中2 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR breast and nodes) as defined by ypT0/Tis/ypN0
研究概览
简要总结
To evaluate efficacy of two parallel cohorts of the neoadjuvant immune-chemotherapy (Nivolumab lead in vs concurrent) combination in participants with TNBC primary breast cancer
研究设计
- 分配方式
- Randomized
- 主要目的
- Nivolumab monotherapy lead in "window" or commencement of nivolumab concurrently with chemotherapy
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Female or male, age >= 18 years
- •ECOG performance status 0-1
- •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
- •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.
- •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
- •Able to start study treatment within 14 days of randomisation
- •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
- •Adequate organ function. All screening laboratory tests should be performed within 14 days of randomisation.
排除标准
- •Confirmed presence of AJCC 8th Edition anatomic Stage 3 or 4 disease
- •Other active malignancy requiring concurrent intervention
- •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
- •Tumour of any size considered inoperable at presentation
- •Multifocal or bilateral invasive breast cancer
- •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
- •Will be offered neoadjuvant breast radiation therapy
- •Undergone or planned for sentinel lymph node biopsy before study therapy
- •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
- •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
- •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
结局指标
主要结局
Pathological complete response (pCR breast and nodes) as defined by ypT0/Tis/ypN0
Pathological complete response (pCR breast and nodes) as defined by ypT0/Tis/ypN0
次要结局
- Pathological complete response (pCR as defined by ypT0/Tis/ypN0) in the higher TIL subgroup (%TIL on baseline H&E 30% or more)
- Pathological complete response (pCR as defined by ypT0/Tis/ypN0) in the PD-L1 positive subgroup (defined as 1% or more immune cell staining using the Ventana SP142 assay)
- Pathological complete response (pCR) in breast (ypT0/Tis)
- Residual cancer burden (RCB)0/1
- Tumour response by WHO Criteria
- Ki67 proliferation marker changes between baseline and surgery
- Safety and tolerability as documented according to NCI-CTCAE V5.0
- Event free survival and overall survival over a 3-year period
研究者
Neon Trial Team
Scientific
ANZ Breast Cancer Trials Group Limited
研究点 (1)
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