CAPItello-290
Research type
Research Study
Full title
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC)
IRAS ID
259679
Contact name
Adesola Obunge
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-004687-64
Duration of Study in the UK
3 years, 3 months, 0 days
Research summary
TANCREDI is a clinical trial being carried out in patients with metastatic or locally advanced (inoperable) triple-negative breast cancer (TNBC). It is being carried out to see if a medicine called capivasertib, given with one of the standards of care, paclitaxel, will work more effectively than paclitaxel alone as a first-line therapy in this type of cancer. This study is split into 2 groups, with one group receiving capivasertib + paclitaxel and the other receiving placebo (which resembles capivasertib) + paclitaxel.
Capivasertib is a drug that stops some signals (PI3K/AKT1/PTEN pathway) from reaching cells in the body. It can stop the cancer cells from growing by stopping these signals. Paclitaxel is a chemotherapy drug that is currently one of the standards of care treatment for TNBC. Paclitaxel will enter cancer cells and stop them from dividing and replacing themselves. This stops the cancer from spreading and growing. Clinical studies have shown that using capivasertib in combination with paclitaxel may led to clinical benefit for patients with TNBC. The target population is adults aged ≥18 years with histologically confirmed, locally advanced (not amenable to resection with curative intent) or metastatic TNBC. The research study is planned to go on for approximately 4 years and will include around 800 patients with TNBC from about 20 countries. This research study will help AstraZeneca AB to answer research questions. Information from this research study may help TNBC patients in the future.REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0070
Date of REC Opinion
2 May 2019
REC opinion
Favourable Opinion