CO41101 - Ipatasertib with atezolizumab and Paclitaxel in TNBC
Research type
Research Study
Full title
A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND PACLITAXEL AS A TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER
IRAS ID
269456
Contact name
Peter Schmid
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2019-000810-12
Duration of Study in the UK
5 years, 10 months, 28 days
Research summary
Globally, breast cancer is the second most common invasive malignancy and the most common cause of cancer-related mortality in women.
Triple-negative breast cancer(TNBC)accounts for approximately 20% of all breast cancers and patients with metastatic TNBC exhibit a particularly poor clinical outcome,generally with rapid progression and a median overall survival of approximately 16 months in a diagnostically unselected population and up to 25 months in patients with tumours expressing PD-L1.
Although TNBC may respond to chemotherapy,including taxanes,there are no approved first-line regimens or targeted therapies for an all-comer population.Because of an increase in toxicity and little survival benefit with combination chemotherapy,treatment with sequential single agents is generally preferred.
Paclitaxel is considered an appropriate first-line regimen,with a median progression-free survival of approximately 6 months.There is a pressing need for clinically active agents for the treatment of TNBC.For patients with locally advanced unresectable and metastatic TNBC,clinical outcome for some patients has improved with the incorporation of atezolizumab,although the prospect for long-term survival remains disappointingly low.
Ipatasertib is designed to block a protein that is known to promote the growth of cancer cells.In animal studies and laboratory experiments ipatasertib has been shown to prevent or slow the growth of many different types of cancer cells,including breast cancer cells.
This study will evaluate the efficacy,safety,and pharmacokinetics of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced unresectable or metastatic TNBC previously untreated in this setting.The combination of ipatasertib, atezolizumab, and paclitaxel will be evaluated in two independently enrolled cohorts.Patients with PD-L1-non-positive and PD-L1-positive tumours will be independently enrolled in Cohorts 1 and 2, respectively.
1150 patients will be recruited globally.Approximately 60 patients at 18 UK sites.The study will last approximately 6 years from first patient screened to last patient last visit.
The study is sponsored by F.Hoffman La Roche
Research Summary;Version1.0(03 Jul 2019)Lay summary of study results: The lay patients summary will be published on the Roche forpatients website by end of March 2024.
Link to forpatients:
lhttps://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkI-2B2FmlpOZCx9oHLzlTYNfEUWaADqb0w2tMtRTl1mlmSXvd-2FwqhxQRBNG0-2FBMI2sWdlNhrsKRzRebLwbjgjvQb-2B5xVXPLz24k7DrwhawdlCCPZ-2BRs3YXdHwzoH2z1MI85CN3RPpt-2BF3t0YbZqh3GcPM-3D_Rks_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81fB-2FQjjyzH-2BmSctwLP5tBx9rtAjA7kjmun1ZgxdpORsJtYady0PDwoNqim2cEG5GKLw-2Bqa-2BWKhh0Evc-2BzWw-2B3ESaZv3LsqumufRvW6H4PCFMvyuNBsBYMEQcdsIMLUBb3j6r8p07y-2BQo0H8vze9EZWBPTMmL1EEUQZkkHMe6Ec9Bg-3D-3D&data=05%7C02%7Criverside.rec%40hra.nhs.uk%7C00b2017d96dd465df75908dc37af1506%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638446472312070911%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2KSlVo0IpXrA5aPwIL%2FazCo7X2zsu%2FBJLQ6lqkDNchY%3D&reserved=0
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: We anticipate the results to be posted on the clinicaltrials.gov website by the end of March 2024.Link to ct.gov:
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkOFEMulGs1SVECP-2FF6YGx8nn1nfExwsCvT47mh8zvdiibrfdQzhAfRNqBlyWjeeJGVbXteSesTwlwbLBZr94iuvXdFQxqSweYVg0ZrGPcDwgOZEkNR77U6JwFvNgpIZLgw-3D-3Dn_T__a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81fB-2FQjjyzH-2BmSctwLP5tBx9fhZepIzq-2BnjwSAORVWjBAQk1n-2BgcL7Cf9ho4ef36jpRADZqNXEwgbGTufr9QEAIp9v5IY70NbZl5Q-2BVPplLXT3rL-2BORJM0E8w90viQ5XcUZOGRGuYs4yDUdEjaaEjx9d1ciWeFzh9uUXoYpW5muZ-2Bg-3D-3D&data=05%7C02%7Criverside.rec%40hra.nhs.uk%7C00b2017d96dd465df75908dc37af1506%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638446472312079911%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=05B%2FRFVi%2BvfHD8Jh60SiUzptJIub0osT%2F5OuJlWnH%2Fs%3D&reserved=0
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1357
Date of REC Opinion
4 Oct 2019
REC opinion
Further Information Favourable Opinion