CAPItello-291
Research type
Research Study
Full title
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment with an Aromatase Inhibitor (CAPItello-291)
IRAS ID
275926
Contact name
Hartmut Kristeleit
Contact email
Eudract number
2019-003629-78
Duration of Study in the UK
3 years, 10 months, 16 days
Research summary
The purpose of this research study is to find out if a new medication called capivasertib given with fulvestrant (a standard of care medication) will work more effectively than fulvestrant alone in treating patients with locally advanced (inoperable) or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2−) breast cancer. Capivasertib is not approved by any health authority, except for use in research studies.
In women, breast cancer is the most frequently diagnosed cancer and the leading cause of cancer deaths worldwide. Although it can be treated, metastatic breast cancer remains incurable with a median survival of approximately 3 years and a 5-year survival rate of around 25%.
Approximately 700 patients will take part in this research study, with 350 patients in each group. The study will last approximately 4 years. Procedures will include, but are not limited to, blood tests, physical examinations, vital signs, electrocardiogram (a test to measure heart activity), questionnaires and radiological or MRI scans to measure the tumour and assess the extent of the cancer.
AstraZeneca AB and AstraZeneca K.K. are funding the research. The study is planned to run at 16 hospitals/cancer centres in the UK.
REC name
London - South East Research Ethics Committee
REC reference
20/LO/0322
Date of REC Opinion
24 Mar 2020
REC opinion
Favourable Opinion