Team Two Oncology Research Breast and Gynaecology

·        Small. PI: Mr Brian Hogan: Open surgery versus minimally invasive vacuum-assisted excision of small screen-detected breast cancer – a phase III randomised multi-centre trial

·        POETIC-A : PI: Mr Baek Kim POETIC-A is a phase III, multi-centre, biomarker–stratified randomised trial. The trial has 2 parts; i) a screening-registration part where patients enriched for the subsequent eligible population receive AI treatment pre-surgery followed by ii) a randomised intervention part where patients whose early AI exposure is indicative of a sub-optimal endocrine response will receive standard endocrine therapy alone or abemaciclib with standard endocrine therapy.

·        ATNEC: PI: Miss Emma MacInnes A randomised trial investigating whether axillary treatment can be avoided in patients with no residual cancer in the lymph glands after chemotherapy.

·        Pre-Nutritive : PI: Sue Hartup To assess the feasibility of collecting nutritional metrics from TNBC patients during standard clinical care pathways and compare this to chemotherapy response

·        Ascent 3: PI: Prof Chris Twelves A Randomised, Open-label, Phase 3 Study of Sacituzumab Govitecan vs TPC in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic TNBC Whose Tumours Do Not Express PD-L1 or in Patients Previously Treated with Anti-PD-(L)1 Agents in the Early Setting Whose Tumours Do Express PD-L1

·        Ascent 4. PI: Prof Twelves: A Randomised, Open-label, Phase 3 Study of Sacituzumab Govitecan vs TPC in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic TNBC Whose Tumours Do Not Express PD-L1 or in Patients Previously Treated with Anti-PD-(L)1 Agents in the Early Setting Whose Tumours Do Express PD-L1

·        AL 2001: PI: Prof Twelves Phase II, open label, single arm study to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the ixabepilone Drug Response prediction (DRP) after failure of an anthracycline and a taxane.(currently paused)

·        Cando-3 : PI: Sue Hartup Body composition and chemotherapy toxicity in women with early breast cancer

·        Destiny Respond  PI: Amy Burkinshaw A multi-center, multi-country prospective observational study of patients initiating T-DXd in the first or second treatment line for HER2+, and HER2-low unresectable and/or metastatic breast cancer

·        Real-World Patient-Reported outcomes: PI: Amy Burkinshaw Real-World Patient-Reported Outcomes in ER+/HER2- Advanced/Metastatic Breast Cancer

• Pairs PI: Dr David Jackson Parp Inhibitor Resistance Study (PAIRS)

• Monitor: PI: Dr David Jackson Multi-centre, observational study to follow patients with ovarian cancer on Niraparib maintenance in the UK

• Valtive-1: PI: Dr Alison Young To define the Progression Free Survival (PFS) difference between Tie2-defined vascular responders and Tie2-defined vascular non-responders in patients receiving bevacizumab for high-risk Ovarian Cancer

• Protector: PI Mr Richard Hutson – The study has three arms: risk reducing salpingo-oophorectomy (RRSO – current standard clinical practice), RRESDO (surgical alternative), control (no surgery). Women are given the option of self-selecting which of the three arms they wish to partake in

• CRAIN: PI: Dr Rachel Cooper A phase 1b TiTE-CRM dose escalation clinical trial of tolinapant (ASTX660) in combination with standard radical chemoradiotherapy in cervical cancer