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

Breast Cancer Trials0 sites108 target enrollmentOctober 7, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 7, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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