Breast Cancer Case Study

Breast Cancer Case Study

Exceeding Expectations Using End-to-end Integration

PPD managed a Phase II ER-positive, HER2-negative breast cancer study with aggressive sponsor expectations. The study consisted of a rapid startup timeline, opportunistic patient enrollment strategy, and early data monitoring coordination (DMC). This randomized, open-label, two-arm study to access the efficiency and safety of the study drug in combination with fulvestrant in postmenopausal women with metastatic breast cancer ultimately yielded DMC to be completed four months ahead of target.

ONE Team approach delivers 34 sites in six countries, 97 patients randomized, with all study milestones completed ahead of target

Actual enrollment rate was 200% better than projected




Rapid startup

  • High-priority identification of initial qualified group of countries/sites based on detailed feasibility data and enrollment metrics
  • Waved pre-study visits by leveraging existing site contract templates and processes with established sites
  • All country approval submissions three months ahead of target
  • 80% of sites activated one month ahead of target

Opportunistic patient recruitment

  • Sites pre-identified patients allowing for rapid enrollment following site activation
  • Conducted timely interventions to take advantage of high-enrolling sites and preventing non-enrolling sites
  • First patient randomized two weeks ahead of target
  • Last patient randomized 10 months ahead of target

Early DMC

  • Used close cross-functional collaboration to track and find efficiencies in data entry, query resolution, data review and source document verification
  • First DMC completed four months ahead of target

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