eoadjuvant Nivolumab and chemotherapy in stage I-II triple negative breast cancer.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 108

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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