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Case study: Study Support Service - Performance Monitoring

 Once your study is open to recruitment, we will work with you to ensure it is making progress by monitoring study-wide performance.

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Study profile and summary

Local Clinical Research Network: North Thames
Study name: IMPassion 130
Type: Commercial overseas funder
Funder: Roche
Number of sites: 30
Recruitment target: 900
Recruitment achieved: 902
Study closed: May 2017

Triple negative breast cancer is one of the more rare types of breast cancer and typically around 10 to 15 per cent of patients diagnosed with breast cancer, will have the triple negative breast cancer type. It is often seen in women under 40 years old and the prognosis can be poor.

Many breast cancers have one or more proteins in the cancer cells and these are called receptors. These receptors are related to the hormones oestrogen and progesterone or the protein HER2. Triple negative breast cancer does not have receptors for these hormones, so hormone treatment and biological therapy doesn’t benefit people with triple negative breast cancer. The standard treatment for this type of cancer includes surgery and chemotherapy.

The IMPasssion 130 study funded by Roche, looks to assess whether adding an immunotherapy drug, to the standard chemotherapy drug, would provide a better outcome for patients with this type of cancer when compared to receiving the standard chemotherapy treatment alone.

“We really benefitted from having an active relationship with the Industry team at the Network. It meant we quickly got to highlight problems and put strategies in place promptly to resolve problems."

Network Impact

The IMPassion 130 study opened to recruitment in June 2015, initially five sites in the UK were recruiting patients to the study. Sarah Anderson, Country Study Manager at Roche, describes how beneficial it was to have dedicated support from the NIHR Clinical Research Network.

“I had frequent contact with our Industry Facilitator at the Network, it was good to know that I could talk to one person who was familiar with the study, which meant that raising issues was much easier.”

Recruitment to the study was proving to be slow and so Roche looked to the Network for support to improve the situation. Sarah continues:

“The open sites were recruiting but it was slow due to patients not meeting the eligibility criteria and we knew that things needed to change if we were going to meet our targets. The Network supported us by helping to open an additional five sites to give us the access to patients we needed.

“The Network also suggested methods of promoting the study to help improve recruitment, such as adding it to the Cancer Research website and promoting it among the Local Clinical Research Network Industry Leads so that it got to the top of the list for clinicians.”

The study closed in May 2017, the UK recruited 44 patients to the study, exceeding its target by four patients. Sarah is delighted with the service she received from the Network:

“We really benefitted from having an active relationship with the Industry team at the Network. It meant we quickly got to highlight problems and put strategies in place promptly to resolve problems. The Network is so familiar with the NHS research environment that they look at problems from a different perspective and that can really help to open up opportunities you just wouldn’t have had access to.”

Insight

The phase 1b study of the combined immunotherapy drug, with the standard chemotherapy drug showed that the combination of drugs shrank tumours in just over 70 per cent of patients. The results of the IMPassion 130 study are expected in early 2018 and the team are hopeful of similar outcomes for patients.