SALTO: Scottish Audit of Lung Toxicity with Novel Oncology Therapies.

  • Purpose: The study aims to evaluate the “real world” impact of the drug Trastuzumab Deruxtecan (T-DXd) on Scottish patients. Specifically, it focuses on monitoring the rates and management of a potentially serious lung side effect called Interstitial Lung Disease (ILD), while simultaneously tracking how well the drug works in extending life and delaying cancer progression.
  • Population: Patients in Scotland receiving T-DXd for HER2-positive or HER2-low metastatic breast cancer.
  • Method: This is a multicentre clinical audit (retrospective data collection). It reviews patient records to see how the drug is performing outside of strictly controlled clinical trials.
  • Key Outcomes: Safety: Rates of Interstitial Lung Disease (ILD) and how it is managed when it occurs. Efficacy: Response Rates (how much the tumour shrinks), Progression-Free Survival (PFS), and Overall Survival (OS).
  • Scope: Pan-Scotland (involving major Scottish cancer centres).
  • Lead Investigator: Sophie Barrett
  • Why it matters T-DXd has been a game-changer for metastatic breast cancer, but it carries a known risk of lung toxicity (ILD/pneumonitis) which can be fatal if not caught early. Clinical trials happen in controlled environments; this audit is necessary to ensure that in the “real world,” Scottish patients are being monitored safely and are achieving the survival benefits seen in global trials.

ESTABLISH: Exploring Suitable Treatments for Advanced Breast cancer patients with Long-term Insomnia through StakeHolder collaboration.

  • Purpose: The study acknowledges that people with secondary breast cancer have often been excluded from previous sleep studies. Its goal is to co-design and test a version of Cognitive Behavioural Therapy for Insomnia (CBT-I) specifically tailored to the needs of those living with metastatic breast cancer.
  • Locations: Recruiting from NHS Greater Glasgow & Clyde and NHS Lothian.
  • Website
  • Funder: The charity Make 2nds Count.
  • Lead Investigator: Dr. Leanne Fleming (Director of the Strathclyde Centre for Sleep Health, University of Strathclyde).
  • Why it matters Research shows that about 50% of newly diagnosed breast cancer patients develop acute insomnia. If untreated, this often becomes a long-term (chronic) problem that is much harder to fix later. This study hopes to “nip it in the bud” during the early treatment phase.

INVEST: INvestigating the Value of Early Sleep Therapy.

  • Purpose: Focusing on people with early breast cancer, this randomised controlled trial aims to test a “prehabilitation” approach — intervening early to stop acute sleep problems from becoming chronic insomnia. It investigates whether Sleep Restriction Therapy (SRT) is a feasible and effective treatment for patients who are currently undergoing cancer treatment.
  • Website
  • Locations: Recruiting from NHS Greater Glasgow & Clyde and NHS Grampian.
  • Funder: Scottish Government’s Chief Scientist Office (CSO).
  • Lead Investigator: Prof. Leanne Fleming (Strathclyde Centre for Sleep Health, University of Strathclyde).
  • Why it matters: Standard sleep therapies often fail metastatic patients because they do not account for physical symptoms (like bone metastasis pain) or the unique psychological burden of incurable cancer. This study ensures these patients are not “left behind” in sleep medicine research.

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